Drug Approvals

New! As of May 1, 2004, New and Generic Drug Approvals 1998-2004, will not be updated.
Please use Drugs@FDA for all drug approval information, which includes the content of this page.

Product Name	Company	Application #	Approval Date	Letter Posted	Label Posted	Review Posted
ZADITOR (ketotifen fumarate ophthalmic solution) 0.025%, Rx	Ciba Vision	NDA 21-066	7/2/99	7/6/99	7/6/99	3/31/02
ZADITOR (ketotifen fumarate ophthalmic solution) 0.025%, Rx	Ciba Vision	NDA 21-066/S4	07/20/01		05/08/03
	ZADITOR Indication: for the prevention of itching of the eye due to allergic conjunctivitis.
Zagam (sparfloxacin) Tablets, 200 mg	Mylan Pharmaceuticals Inc.	NDA 20-677/S-004	10/2/02	10/11/01	10/4/02
Zagam (sparfloxacin) Tablets, 200 mg, Rx	Mylan Pharmaceuticals Inc.	NDA 20-677/S-006	4/4/03	4/18/03	4/18/03
Zanaflex (tizanidine) Tablets, 2 mg and 4 mg, Rx	Elan Pharmaceuticals	NDA 20-397/S-014	11/27/02	12/9/02
ZANOSAR (streptozocin) Sterile Powder,	Pharmacia & Upjohn Company	NDA 50-577/S-016	1/22/03	1/27/03
ZANOSAR (streptozocin) Sterile Powder,	Pharmacia & Upjohn Company	NDA 50-577/S-014	12/30/02	7/30/03
Zantac (ranitidine hydrochloride) Efferdose,	GlaxoSmithKline	NDA 20251/S15	4/1/04	4/7/04
Zantac (ranitidine hydrochloride) Efferdose	Glaxo Wellcome, Inc.	NDA 20251/S-6	10/29/99			4/25/03
Zantac (ranitidine hydrochloride) Injection	Glaxo Wellcome, Inc.	NDA 19-090/S-0037	10/29/99			4/16/03
Zantac (ranitidine hydrochloride) Injection & Premixed Injection	GlaxoSmithKline	NDA 19-090/S-045 & 19-593/S-033	1/7/02	2/8/02
Zantac (ranitidine hydrochloride) Tablets, Syrup, USP, GELdose Capsules & EFFERdose Tablets and Granules	GlaxoSmithKline	NDA 18-703/S-061, 19-675/S-025, 20-095/S-013 & 20-251/S-011	1/7/02	2/8/02
Zantac (Ranitidine Hydrochloride) Premixed Injection	Glaxo Wellcome Research and Development	NDA 19-593/S-028	10/29/99			4/30/03
Zantac (Ranitidine Hydrochloride) Syrup	Glaxo Wellcome Research and Development	NDA 19-675/S-020	10/29/99			4/30/03
Zantac (Ranitidine Hydrochloride) Geldose Capsules	Glaxo Wellcome Research and Development	NDA 20-095/S7	10/29/99			4/29/03
Zantac (Ranitidine Hydrochloride) Tablets	Glaxo Wellcome Research and Development	NDA 018703/S56	10/29/99			4/16/03
Zantac 75 (Ranitidine Hydrochloride) Tablets	Glaxo Wellcome, Inc.	NDA 20520/S-001	6/8/98			7/11/00
Zarontin (ethosuximide) Capsules,	Pfizer Inc.	NDA 12-380/S29	4/19/02	5/2/02
Zarontin (ethosuximide) 250 mg Capsules and 250 mg/5 ml Syrup.	Parket-Davis	NDA 12380/S-22/23/25	4/9/01	5/4/01
Zaroxolyn (metolazone) Tablets & Mykrox (metolazone) Tablets, 2.5, 5 and 10 mg & 0.5 mg respectively, Rx	Celltech Pharmaceuticals, Inc.	NDA 17-386/S-034 & 19-532/S-015	10/29/02	11/19/02
Zaroxolyn (metolazone) Tablets & Mykrox (metolazone) Tablets, 2.5, 5 and 10 mg & 0.5 mg respectively, Rx	Celltech Pharmaceuticals, Inc.	NDA 17-386/S-032	8/10/01	6/16/03
Zavesca (Miglustat) Capsules, 100 mg, Rx	Actelion Pharmaceuticals	NDA 21-348	7/31/03	8/15/03	8/15/03	12/15/03
Zebeta (Bisoprolol Fumarate) Tablets, 5 & 10 mg	Wyeth-Ayerst Laboratories	NDA 19-982/S5	6/23/98			8/1/01
Zebeta (Bisoprolol Fumarate) Tablets, 5 & 10 mg	Lederle Laboratories	NDA 19-982/S6	2/19/98			8/1/01
Zelnorm (tegaserod maleate) Tablets,	Novartis Pharmaceuticals Corporation	NDA 21-200/S9
Zelnorm (tegaserod maleate) Tablets,	Novartis Pharmaceuticals Corporation	NDA 21-200/S7 & S8
Zelnorm (tegaserod maleate) Tablets,	Novartis Pharmaceuticals Corporation	NDA 21-200	7/24/02	8/6/02	7/24/02	10/23/02
Zemplar (paricalcitol) Injection, 2 mcg/ml and 5 mcg/ml vials, Rx	Abbott Laboratories	NDA 20-819/S-014	3/31/04		4/7/04
Zemuron (rocuronium bromide) Injection, Rx	Organon, Inc.	NDA 20-214/S-017	6/4/03
Zemuron (rocuronium bromide) Injection, Rx	Organon, Inc.	NDA 20-214/S16	2/6/04	3/3/04
Zemplar (paricalcitol injection), Rx	Abbott Laboratories	NDA 20-819/S14	3/31/04	4/7/04
Zemplar (paricalcitol injection), Rx	Abbott Laboratories	NDA 20-819/S7, S11	2/24/03	3/10/03
Zemplar (paricalcitol injection), 5 mcg/mL	Abbott Laboratories	NDA 20-819/S-003	2/2/00	2/4/00	2/4/00
	Zemplar Indicated: For the prevention and treatment of secondary hyperparathyroidism associated with chronic renal failure.
Zemplar (paricalcitol) Injection	Abbott Laboratories	NDA 20-819	4/17/98	5/6/98	5/8/98	6/19/01
Zerit XR (stavudine) Extended-Release Capsules, 37.5 mg, 50 mg, 75 mg, and 100 mg,	Bristol-Myers Squibb Company	NDA 21-453	12/31/02	1/30/03	4/9/03
ZERIT (stavudine) Capsules and Pediatric Oral Solution (POS).	Bristol-Myers Squibb Company	NDA 20-412/S15	10/16/01		4/22/03
ZERIT (stavudine) Capsules and Pediatric Oral Solution (POS),	Bristol-Myers Squibb Company	NDA 20-412/S16 & 20-413/S7	3/29/02	4/8/02	3/29/02
ZERIT (stavudine) Capsules and Pediatric Oral Solution (POS).	Bristol-Myers Squibb Company	NDA 20-412/S17, S18 & 20-413/S8, S9	2/20/02	2/21/02
ZERIT (stavudine) for Oral Solution	Bristol-Myers Squibb Company	NDA 20-413/S6	10/16/01		4/25/03
Zestoretic (lisinopril/hydrochlorothiazide) Tablets, 20/12.5, 20/25 and 10/12.5 mg, Rx	AstraZeneca Pharmaceuticals LP	NDA 19-888/S-035	4/17/03
Zestril (lisinopril) Tablet, 2.5, 5, 10, 20, 30 & 40 mg, Rx	AstraZeneca Pharmaceuticals	NDA 19-777/S-044/42	7/1/03	7/6/03	7/8/03
Zestril (lisinopril) Tablet, 2.5, 5, 10, 20, 30 & 40 mg, Rx	AstraZeneca Pharmaceuticals	NDA 19-777/S43	3/30/04	4/7/04
Zestril (lisinopril) Tablet, 2.5, 5, 10, 20, & 40 mg, Rx	Zeneca Pharmaceuticals	NDA 19-777/S-033	5/1/98			8//8/01
Zestril (lisinopril) Tablet, 2.5, 5, 10, 20, & 40 mg, Rx	Zeneca Pharmaceuticals	NDA 19-777/S-034	11/6/98			8//8/01
Zestril (lisinopril) Tablet, 2.5, 5, 10, 20, & 40 mg, Rx	Zeneca Pharmaceuticals	NDA 19-777/S-035	1/20/99			6/22/01
Zestril (lisinopril), Tablet/Oral, Rx	Zeneca Pharmaceuticals	NDA 19-777/S-037	2/7/00	2/14/00
	Zestril Indications: This supplemental new drug application provides for changes in several sections of the package insert to incorporate statements concerning the use of high doses of lisinopril to reduce the risk of the combined outcomes of mortality and hospitalization in patients with congestive heart failure. These statements are based on the results of the "Assessment of Treatment with Lisinopril and Survival (ATLAS)" study.
Zetia (ezetimibe) Tablets, 10 mg, Rx	MSP Singapore Company, LLC	NDA 21-445	10/25/02	10/30/02	10/25/02	2/3/03
Ziac (bisoprolol fumarate and hydrochlorothiazide) Tablets and Zebeta (bisoprolol fumarate) Tablets, 2.5/6.25 mg, 5/6.25 mg, and 10/6.25 mg & 5 and 10 mg, respectively, Rx	Wyeth Pharmaceuticals	NDAs 20-186/S-015 and 19-982/S-010	1/24/03	1/27/03
Ziagen (abacavir sulfate) Tablets and Oral Solution,	GlaxoSmithKline	NDA 20-977/S11 & NDA 20-978/S13	4/15/04
Ziagen (abacavir sulfate) Tablets and Oral Solution,	GlaxoSmithKline	NDA 20-977/S10 & NDA 20-978/S12	7/17/03	7/28/03	9/25/03
Ziagen (abacavir sulfate) Tablets and Oral Solution,	GlaxoSmithKline	NDA 20-977/S8 & NDA 20-978/S10	8/14/02	8/21/02	8/14/02
Ziagen (abacavir sulfate) Tablets and Oral Solution,	GlaxoSmithKline	NDA 20-977/S7 & NDA 20-978/S8	10/2/02	10/11/01	10/3/02
Ziagen (abacavir sulfate) Tablets and Oral Solution,	GlaxoSmithKline	NDA 20-977/S5 & NDA 20-978/S6	1/28/02	3/6/02
Ziagen (abacavir sulfate) Tablets and Oral Solution,	Glaxo Wellcome Inc.	NDA 20-977/S2 & NDA 20-978/S2	12/15/00			4/14/04
Ziagen (abacavir sulfate) Tablets and Oral Solution,	Glaxo Wellcome Inc.	NDA 20-977 & NDA 20-978	12/17/98	1/6/99	1/6/99	4/4/02
	Ziagen Indications: For the treatment of HIV-1 infection in adults and children (ages 3 months and above). This indication is based on analyses of surrogate markers in controlled studies up to 24 weeks in duration.
Zinacef (Cefuroxime for Injection and Dextrose Injection) USP, Rx	B. Braun Medical Inc.	NDA 50-780	2/21/01
	Zinacef Indications: Lower respiratory tract infections, urinary tract infections, skin and skin structure infections, septicemia, meningitis, gonorrhea, and bone and joint infections (same as Zinacef).
Zinacef (Cefuroxime for Injection)	GlaxoSmithKline	NDA 50-558/S-050	10/12/01		5/2/03
Zinacef (Cefuroxime for Injection)	GlaxoSmithKline	NDA 50-643/S-	10/12/01		5/2/03
Zinc Chloride Injection, USP, Rx	Abbott Laboratories	NDA 18-959/S-008, S-011	2/14/03	2/25/03
ZINECARD (dexrazoxane) Injection, Rx	Pharmacia & Upjohn Company	NDA 20-212/S-004/S-005/S-006	10/31/02	11/18/02	11/1/02
Zithromax (azithromycin) Oral Suspension,	Pfizer Inc.	NDA 50-710/S19	4/27/04
Zithromax (azithromycin) Oral Suspension & Tablets,	Pfizer Inc.	NDA 50-710/S17/S21, 50-711/S15/S17	1/15/04	1/22/04	1/22/04
Zithromax (azithromycin) Oral Suspension & Tablets,	Pfizer Inc.	NDA 50-710/S20, 50-711/S16 & 50-784/S5	12/18/03	12/22/03
Zithromax (azithromycin) Tablets, 500 mg,	Pfizer Inc.	NDA 50-784/S4/S6	1/15/04	1/22/04	1/22/04
Zithromax TRI-PAK (azithromycin) Tablets, 500 mg,	Pfizer Inc.	NDA 50-784/S2	10/16/02	10/21/02
Zithromax TRI-PAK (azithromycin) Tablets, 500 mg,	Pfizer Inc.	NDA 50-784	5/24/02	6/3/02	10/22/02	10/22/02
Zithromax (Azithromycin) Oral Suspension, Rx	Pfizer Inc.	NDA 50-710/S-016	6/20/03	7/6/03
Zithromax (Azithromycin) Capsules, Single Dose Packet &Tablets, Rx	Pfizer Inc.	NDA 50-670/S22, 50-693/S9 & 50-730/S12	1/15/04	1/22/04
Zithromax (Azithromycin) Capsules, Single Dose Packet &Tablets, Rx	Pfizer Inc.	NDA 50-670/S21, 50-693/S8 & 50-730/S11	3/24/04	3/28/04	4/6/04
Zithromax (AzithromycinDihydrate) Capsules, Single Dose Packet, Oral Suspension, Tablets & IV, 250 & 600 (Mac) mg tablets, Rx	Pfizer Inc.	NDA 50-670/S19, 50-693/S7, 50-710/S-014, 50-711/S-012, 50-733/S-010 & 50-730/S10	7/22/02	7/24/02
Zithromax (Azithromycin) Capsules, Single Dose Packet & Tablets,	Pfizer Inc.	NDA 50-670/S17, 50-693/S5 & 50-730/S7	10/16/02	10/21/02
Zithromax (Azithromycin) Capsules, Single Dose Packet & Tablets	Pfizer Inc.	NDA 50-670/S15, 50-693/S3 & 50-730/S5	11/13/00			11/9/01
Zithromax (azithromycin tablets)	Pfizer, Inc.	NDA 50-710/S8	12/14/01		5/2/03
Zithromax (azithromycin tablets)	Pfizer, Inc.	NDA 50-710/S9	12/14/01		5/2/03
Zithromax (azithromycin for injection), I.V., Rx	Pfizer, Inc.	NDA 50-733/S-05	2/28/01		5/2/03
Zithromax (azithromycin) Injection, I.V., Rx	Pfizer, Inc.	NDA 50-733/S13	1/15/04	1/22/04
Zithromax (azithromycin) Injection, I.V., Rx	Pfizer, Inc.	NDA 50-733/S12	1/15/04	1/22/04
Zithromax (azithromycin for injection), I.V., Rx	Pfizer, Inc.	NDA 50-733/S-009	3/13/02	3/29/02
Zithromax (azithromycin for injection), I.V., Rx	Pfizer, Inc.	NDA 50-733/S-007	6/12/03	7/8/03
Zithromax (azithromycin for injection), I.V., Rx	Pfizer, Inc.	NDA 50-733/S-006	10/16/02	10/21/02
Zithromax (azithromycin) Oral Suspension and Tablets,	Pfizer Inc.	NDA 50-710/S7 & 50-711/S8	10/16/02	10/21/02
Zithromax (azithromycin) Pediatric Oral Suspension, and Zithromax (azithromycin)Tablets,	Pfizer Inc.	NDA 50-710/S11 & 50-711/S9	5/24/02	6/3/02	5/28/02
Zithromax (azithromycin) for Oral Suspension, Rx	Pfizer, Inc.	NDA 50-710/S-008/S-009	12/14/01	1/18/01	1/18/01
Zocor (Simvastatin) Tablets, Rx	Merck	NDA 19-766/S67 & S68	2/24/04	2/25/04	4/5/04
Zocor (Simvastatin) Tablets, Rx	Merck	NDA 19-766/S-027	3/31/98	5/6/98		4/30/02
Zocor (simvastatin) Tablets, Rx	Merck	NDA 19-766/ S-026, S-028	7/10/98	7/10/98		11/12/98
	Zocor indication: These supplemental new drug applications provide for the use of a new dosage strength and dosing regimen (80 mg per day) of Zocor, (S-028) and for a new indication for the treatment of patients with homozygous familial hypercholesterolemia (S-026).
Zocor (simvastatin) Tablets, Rx	Merck	NDA 19-766/ S-029	6/29/98			10/23/98
Zocor (simvastatin) Tablets, Rx	Merck	NDA 19-766/ S-032	8/5/99	8/6/99
	Zocor Indication (S32): This supplemental new drug application provides for the additional indication of increasing HDL-C in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Frederickson Types IIa and IIb). The revised first paragraph of the "Hyperlipidemia" subsection of INDICATIONS AND USAGE will state "Zocor is indicated as an adjunct to diet to reduce elevated total-C, LDL-C, Apo B, and TG levels, and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial andnonfamilial) and mixed dyslipidemia (Frederickson Types IIa and IIb)."
Zocor (simvastatin) Tablets, Rx	Merck	NDA 19-766/ S-034 & S-036	11/22/99			7/6/00, 7/6/00
Zocor (simvastatin) Tablets, Rx	Merck	NDA 19-766/ S-040	4/27/00	4/28/00		6/4/01
Zocor (simvastatin) Tablets, Rx	Merck	NDA 19-766/ S-042	11/7/00
Zocor (simvastatin) Tablets, Rx	Merck & Co., Inc.	NDA 19-766/S51	5/6/02	5/9/02	5/6/02
Zocor (simvastatin) Tablets, Rx	Merck & Co., Inc.	NDA 19-766/S52	3/21/02	3/29/02	3/21/02	7/5/02
Zocor (simvastatin) Tablets, Rx	Merck & Co., Inc.	NDA 19-766/S53	11/14/01		6/16/03
Zocor (simvastatin) Tablets, Rx	Merck & Co., Inc.	NDA 19-766/S56	10/18/02	10/28/02	10/18/02
Zocor (simvastatin) Tablets, Rx	Merck & Co., Inc.	NDA 19-766/S58	4/16/03		4/17/03
Zocor (simvastatin) Tablets, Rx	Merck & Co., Inc.	NDA 19-766/S65 & S66	9/17/03	9/29/03	9/25/03
Zofran & Zofran ODT (ondansetron) Tablets & Orally Disintegrating Tablets, Rx	GlaxoSmithKline	NDA 20-103/S-21 & 20-781/S-03	1/31/03	2/12/03
Zofran (ondansetron) Tablets, Rx	Glaxo Wellcome	NDA 20-103/S-018 20-605/S-005 20-718/S-002	12/13/00	2/20/01	2/20/01
Zofran (ondansetron) Tablets	Glaxo Wellcome	NDA 20-103/SE1-015	8/27/99			7/3/00
	Zofran Indication: For the prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin.
Zofran ODT (odansetron) Orally Disintegrating Tablets	Glaxo Wellcome Inc.	NDA 20-781	1/27/99	1/27/99	1/27/99	5/23/01
	Zofran indication: For prevention of chemotherapy and radiation-induced nausea and vomiting, and prevention of postoperative nausea and vomiting.
Zoladex (goserelin acetate) Implant, 3.6 & 10.8 mg	AstraZeneca Pharmaceuticals LP	NDA 19-726/S-037 & 20-578/S-016	2/28/02	3/5/02
Zoladex (goserelin acetate) Implant, 3-Month 10.8 mg Depot	AstraZeneca Pharmaceuticals LP	NDA 20-578/S13	2/5/02	4/17/02
Zoladex (goserelin acetate) Implant, 3.6 mg	AstraZeneca Pharmaceuticals LP	NDA 19-726/S-034	2/5/02	4/17/02		8/6/01
Zoladex (goserelin acetate) Implant, 3.6 mg	Zeneca Pharmaceuticals Inc.	NDA 19-726/S-022	4/9/98			8/6/01
Zoladex (goserelin acetate), 3.6 mg and 10.8 mg Depots	Zeneca	NDA 19-726/S-024 & 20-578/S-003	7/27/98	7/28/98	7/28/98	8/6/01
	Zoladex indication: For the use of Zoladex (goserelin acetate) 3.6 mg and 10.8 mg Depots in combination with flutamide for the management of locally confined Stage T2b-T4 (Stage B2-C) cacinoma of the prostate.
Zoloft (sertraline hydrochloride) Tablets & Oral Concentrate, Rx	Pfizer, Inc.	NDA 19-839/S045 & 20-990/S011	2/7/03	2/12/03	2/13/03
Zoloft (sertraline hydrochloride) Tablets & Oral Concentrate, Rx	Pfizer	NDA 19-839/S44 & 20-990/S10	9/16/03	9/25/03	9/25/03
Zoloft (sertraline hydrochloride) Tablets & Oral Concentrate, Rx	Pfizer Pharmaceuticals	NDA 19-839/S043 & 20-990/S009	9/18/02	9/20/02
Zoloft (sertraline) Tablets & Oral Concentrate, Rx	Pfizer Inc.	NDA 19-839/S039 & 20-990/S007	5/16/02	5/21/02	5/16/02
	Zoloft Indication: PMDD (Premenstrual Dysphoric Disorder).
Zoloft (sertraline hydrochloride) Tablets & Oral Concentrate,	Pfizer Pharmaceuticals	NDA 19-839/S036 & 20-990/S004	9/20/02	9/27/02
Zoloft (sertraline hydrochloride) Tablets & Oral Concentrate	Pfizer Pharmaceuticals, Inc.	NDA 19-839/S035 & 20-990/S003	8/17/01	11/6/01	11/7/01	11/7/01
Zoloft (sertraline hydrochloride) Tablets & Oral Concentrate	Pfizer Inc.	NDA 20-990/S-002 & S004	9/20/02	7/23/03
Zoloft (sertraline hydrochloride) Tablets & Oral Concentrate	Pfizer Inc.	NDA 19-839/S033 & 20-990/S-001	10/12/01	7/31/03	04/25/03
Zoloft (sertraline hydrochloride) Tablets	Pfizer Inc.	NDA 19-839/S026	12/7/99			7/26/01
Zoloft (sertraline hydrochloride) oral concentrate, 20 mg/ml	Pfizer Pharmaceuticals	NDA 20-990	12/7/99	12/28/99	12/28/99	5/29/01
	Zoloft indication: depression, OCD, and panic disorder.
Zolpidem Tartrate Tablets, 5 & 10 mg, Rx Tentatively Approved	Mylan Pharmaceuticals	ANDA 76-578	7/17/03
Zolpidem Tartrate Tablets, 5 & 10 mg, Rx Tentatively Approved	Par Pharmaceutical, Inc.	ANDA 76-062	4/26/02
Zometa (zoledronic acid) Injection,	Novartis Pharmaceuticals Corporation	NDA 21-223/S8	3/24/04	3/28/04	4/6/04
Zometa (zoledronic acid) Injection,	Novartis Pharmaceuticals Corporation	NDA 21-223/S004	3/7/03	3/26/03	3/26/03
Zometa (zoledronic acid) Injection,	Novartis Pharmaceuticals Corporation	NDA 21-386S1 & 21-223/S6	2/27/04	3/3/04
Zometa (zoledronic acid) Injection,	Novartis Pharmaceuticals Corporation	NDA 21-386 NDA 21-223/S003	2/22/02	3/7/02	2/22/02	7/5/02
Zometa (zoledronic acid) Injection	Novartis Pharmaceuticals Corporation	NDA 21-223	8/20/01	11/5/01	11/5/01	11/8/01
Zomig (zolmitriptan) Nasal Spray,	AstraZeneca	NDA 21-450	9/30/03	10/10/03	10/10/03
Zomig (zolmitriptan) tablets,	AstraZeneca Pharmaceuticals LP	NDA 20-768/S-006	1/29/02	3/6/02
Zomig & Zomig-ZMT (zolmitriptan) Tablets, Rx	AstraZeneca Pharmaceuticals LP	NDA 20-768/S13 & 21-231/S5	1/8/04	1/14/04
Zomig (zolmitriptan) tablets & Zomig-ZMT (zolmitritpan) Orally Disintegrating Tablets, Rx	AstraZeneca Pharmaceuticals LP	NDA 20-768/S-010 & 21-231/S-03	10/9/02	10/21/02
Zomig-ZMT (zolmitritpan) Orally Disintegrating Tablets, Rx	AstraZeneca	NDA 21-231	2/13/01	3/30/01	3/30/01
	Zomig Indications: Acute treatment of Migraine.
Zonalon (doxepin hydrochloride) Cream, 5%,	Bioglan Pharmaceuticals Company	NDA 20-126/S-006	12/20/02	1/29/03	4/4/03
Zonegran (zonisamide) Capsules, 100mg, Rx	Dainippon Pharmaceutical	NDA 20-789/S-5	10/7/02	10/11/01	10/8/02
Zonegran (zonisamide) Capsules, Rx	Dainippon Pharmaceutical	NDA 20-789/S1	8/22/03	8/28/03	8/28/03
Zonegran (zonisamide) Capsules, 100mg, Rx	Dainippon Pharmaceutical	NDA 20-789	3/27/00	3/31/00	3/31/00	5/1/02
Zaroxolyn & Mykrox (metolazone) Tablets,	Celltech Pharmaceuticals	NDA 17-386/S-036 & NDA 19-532/S-016	8/19/03
Zorbtive [Somatotropin (rDNA Origin)] Injection, Rx	Serono, Inc.	NDA 21-597 & 20-604/S26	12/1/03	12/4/03	12/8/03
Zosyn (Piperacillin Sodium & Tazobactam Sodium) Injection, in Galaxy Containers PL2040 Plastic	Wyeth Pharmaceuticals	NDA 50-750/S8	5/6/03	7/9/03	5/13/03
Zosyn (Piperacillin Sodium & Tazobactam Sodium) Injection, in Galaxy Containers PL2040 Plastic	Wyeth Pharmaceuticals	NDA 50-750/S7	5/6/03	7/9/03	5/13/03
Zosyn (Piperacillin Sodium & Tazobactam Sodium) Injection, in Galaxy Containers PL2040 Plastic	Lederle Piperacillin, Inc.	NDA 50-750	2/24/98	7/8/99		7/8/99
Zosyn (Piperacillin Sodium & Tazobactam Sodium) Injection, Rx	Wyeth Pharmaceuticals	NDA 50-684/S38	1/30/04	1/3/04
Zosyn (Piperacillin Sodium & Tazobactam Sodium) Injection, Rx	Wyeth Pharmaceuticals	NDA 50-684/S35	5/1/03	7/9/03
Zosyn (Piperacillin Sodium & Tazobactam Sodium) Injection, Rx	Wyeth Pharmaceuticals	NDA 50-684/S33	4/28/03
Zosyn (Sterile Piperacillin Sodium & Tazobactam Sodium) Injection, Rx	Wyeth-Ayerst Research	NDA 50-750/S3 & 50-684/S15	3/27/02	4/8/02
Zotrim (Sulfamethoxazole and Trimethoprim Tablets, USP and Phenazopyridine Hydrochloride) Tablets, USP	ABLE Laboratories Inc.	NDA 21-105	6/26/01	11/6/01	11/6/01	11/7/01
	Zotrim Indication: Treatment of urinary tract infections and for the symptomatic relief of pain, burning, urgency, frequency, and other discomforts arising from irritation of the lower urinary tract mucosa caused by infection.
Zovirax	GlaxoSmithKline	NDA 18-828/S-026 & S-027			4/15/03
Zovirax (Acyclovir) Cream,	GlaxoSmithKline	NDA 21-478/S3	1/23/04	2/2/04
Zovirax (Acyclovir), Cream	GlaxoSmithKline	NDA 21-478	12/30/02		4/9/03	7/8/03
Zovirax (Acyclovir Sodium) Injection,	GlaxoSmithKline	NDA 18-603/S-023, S-024 & S-025	1/29/02	3/6/02
Zovirax (Acyclovir Sodium) for Injection, 10-mL and 20-mL vials	Glaxo Wellcome	NDA 18603/S-019	6/2/98	6/2/98	6/2/98
Zyban (bupropion hydrochloride) Sustained-Release Tablets,	GlaxoSmithKline	NDA 20-711/S13, S14, S16 & S18	2/14/03	2/25/03	2/25/03
Zyban (bupropion hydrochloride) extended-release tablets.	GlaxoSmithKline	NDA 20-711/S-015	2/21/02	2/21/02
Zyban (bupropion hydrochloride) Sustained-Release Tablets,	GlaxoSmithKline	NDA 20-711/S-012	2/7/01	5/30/02	5/30/02	5/30/02
Zyflo (zileutin tablets) Filmtab, Rx	Abbott Laboratories	NDA 20-471/S-009	12/16/02	1/29/03
Zyloprim (allopurinol) Tablets,	Prometheus Laboratories	NDA 16-084/S-041	7/17/02	8/6/02
Zymar (gatifloxacin) ophthalmic solution, 0.3%	Allergan, Inc.	NDA 21-493	3/28/03	4/1/03	4/1/03
Zyprexa IntraMuscular (olanzapine) Injection, Rx	Eli Lilly & Co.	NDA 21-253	3/29/04	4/7/04	4/6/04
Zyprexa (olanzapine) Tablets, Rx	Eli Lilly & Co.	NDA 20-592/S19	1/14/04	1/22/04	1/22/04
Zyprexa (olanzapine) Tablets, 2.5, 5, 7.5, 10, 15 & 20 mg, Rx	Eli Lilly & Co.	NDA 20-592/S18	7/10/03	7/28/03	7/10/03
	Zyprexa Indications: Short-term treatment of acute manic episodes associated with Bipolar I Disorder, either as monotherapy (S-006) or in combination with lithium or valproate (S-018).
Zyprexa (olanzapine) Tablets, Rx	Eli Lilly & Co.	NDA 20-592/SE1-011	11/9/00			4/14/04
Zyprexa Zydis (olanzapine orally disintegrating) Tablets, Rx	Eli Lilly & Co.	NDA 21-086	4/6/00	4/13/00	4/13/00	7/31/01
Zyrtec (cetirizine hydrochloride) Tablets, Syrup & Extended-Release Tablets, Rx	Pfizer	NDA 19-835/S16, 21-150/S5 & 20-346/S11	3/17/04	3/23/04	4/7/04
Zyrtec (cetirizine hydrochloride) Tablets, 5 and 10 mg, and Syrup, 1mg/ml, Rx	Pfizer Pharmaceuticals	NDA 19-835/S-015 & 20-346/S-008	10/21/02	10/28/02	10/25/02
Zyrtec (cetirizine HCl) Tablets,	Pfizer	NDA 21-621	3/16/04	3/19/04
Zyrtec (cetirizine HCl) Tablets	Pfizer	NDA 19-835/S-005	5/15/98	5/15/98		5/22/01
Zyrtec (cetirizine HCl) Syrup	Pfizer	NDA 20-346/S-002	5/15/98	5/15/98		5/22/01
	Zyrtec Indication: These supplements provide for the use of Zyrtec in pediatric patients 2 to 5 years of age for the indications seasonal and perennial allergic rhinitis and chronic idiopathic urticaria.
Zyrtec-D 12 hr. Extended-Release Tablets (Cetirizine Hydrochloride & Pseudoephedrine Hydroc

Product Name

Company

Application #

Approval
Date

Letter
Posted

Label
Posted

Review
Posted

ZADITOR (ketotifen fumarate ophthalmic solution) 0.025%, Rx

Ciba Vision

NDA 21-066

7/2/99

7/6/99

3/31/02

ZADITOR (ketotifen fumarate ophthalmic solution) 0.025%, Rx

Ciba Vision

NDA 21-066/S4

07/20/01

05/08/03

ZADITOR Indication: for the prevention of itching of the eye due to allergic conjunctivitis.

Zagam (sparfloxacin) Tablets, 200 mg

Mylan Pharmaceuticals Inc.

NDA 20-677/S-004

10/2/02

10/11/01

10/4/02

Zagam (sparfloxacin) Tablets, 200 mg, Rx

Mylan Pharmaceuticals Inc.

NDA 20-677/S-006

4/4/03

4/18/03

Zanaflex (tizanidine) Tablets, 2 mg and 4 mg, Rx

Elan Pharmaceuticals

NDA 20-397/S-014

11/27/02

12/9/02

ZANOSAR (streptozocin) Sterile Powder,

Pharmacia & Upjohn Company

NDA 50-577/S-016

1/22/03

1/27/03

ZANOSAR (streptozocin) Sterile Powder,

Pharmacia & Upjohn Company

NDA 50-577/S-014

12/30/02

7/30/03

Zantac (ranitidine hydrochloride) Efferdose,

GlaxoSmithKline

NDA 20251/S15

4/1/04

4/7/04

Zantac (ranitidine hydrochloride) Efferdose

Glaxo Wellcome, Inc.

NDA 20251/S-6

10/29/99

4/25/03

Zantac (ranitidine hydrochloride) Injection

Glaxo Wellcome, Inc.

NDA 19-090/S-0037

10/29/99

4/16/03

Zantac (ranitidine hydrochloride) Injection & Premixed Injection

GlaxoSmithKline

NDA 19-090/S-045 & 19-593/S-033

1/7/02

2/8/02

Zantac (ranitidine hydrochloride) Tablets, Syrup, USP, GELdose Capsules & EFFERdose Tablets and Granules

GlaxoSmithKline

NDA 18-703/S-061, 19-675/S-025, 20-095/S-013 & 20-251/S-011

1/7/02

2/8/02

Zantac (Ranitidine Hydrochloride) Premixed Injection

Glaxo Wellcome Research and Development

NDA 19-593/S-028

10/29/99

4/30/03

Zantac (Ranitidine Hydrochloride) Syrup

Glaxo Wellcome Research and Development

NDA 19-675/S-020

10/29/99

4/30/03

Zantac (Ranitidine Hydrochloride) Geldose Capsules

Glaxo Wellcome Research and Development

NDA 20-095/S7

10/29/99

4/29/03

Zantac (Ranitidine Hydrochloride) Tablets

Glaxo Wellcome Research and Development

NDA 018703/S56

10/29/99

4/16/03

Zantac 75 (Ranitidine Hydrochloride) Tablets

Glaxo Wellcome, Inc.

NDA 20520/S-001

6/8/98

7/11/00

Zarontin (ethosuximide) Capsules,

Pfizer Inc.

NDA 12-380/S29

4/19/02

5/2/02

Zarontin (ethosuximide) 250 mg Capsules and 250 mg/5 ml Syrup.

Parket-Davis

NDA 12380/S-22/23/25

4/9/01

5/4/01

Zaroxolyn (metolazone) Tablets & Mykrox (metolazone) Tablets, 2.5, 5 and 10 mg & 0.5 mg respectively, Rx

Celltech Pharmaceuticals, Inc.

NDA 17-386/S-034 & 19-532/S-015

10/29/02

11/19/02

Zaroxolyn (metolazone) Tablets & Mykrox (metolazone) Tablets, 2.5, 5 and 10 mg & 0.5 mg respectively, Rx

Celltech Pharmaceuticals, Inc.

NDA 17-386/S-032

8/10/01

6/16/03

Zavesca (Miglustat) Capsules, 100 mg, Rx

Actelion Pharmaceuticals

NDA 21-348

7/31/03

8/15/03

12/15/03

Zebeta (Bisoprolol Fumarate) Tablets, 5 & 10 mg

Wyeth-Ayerst Laboratories

NDA 19-982/S5

6/23/98

8/1/01

Zebeta (Bisoprolol Fumarate) Tablets, 5 & 10 mg

Lederle Laboratories

NDA 19-982/S6

2/19/98

8/1/01

Zelnorm (tegaserod maleate) Tablets,

Novartis Pharmaceuticals Corporation

NDA 21-200/S9

Zelnorm (tegaserod maleate) Tablets,

Novartis Pharmaceuticals Corporation

NDA 21-200/S7 & S8

Zelnorm (tegaserod maleate) Tablets,

Novartis Pharmaceuticals Corporation

NDA 21-200

7/24/02

8/6/02

7/24/02

10/23/02

Zemplar (paricalcitol) Injection, 2 mcg/ml and 5 mcg/ml vials, Rx

Abbott Laboratories

NDA 20-819/S-014

3/31/04

4/7/04

Zemuron (rocuronium bromide) Injection, Rx

Organon, Inc.

NDA 20-214/S-017

6/4/03

Zemuron (rocuronium bromide) Injection, Rx

Organon, Inc.

NDA 20-214/S16

2/6/04

3/3/04

Zemplar (paricalcitol injection), Rx

Abbott Laboratories

NDA 20-819/S14

3/31/04

4/7/04

Zemplar (paricalcitol injection), Rx

Abbott Laboratories

NDA 20-819/S7, S11

2/24/03

3/10/03

Zemplar (paricalcitol injection), 5 mcg/mL

Abbott Laboratories

NDA 20-819/S-003

2/2/00

2/4/00

Zemplar Indicated: For the prevention and treatment of secondary
hyperparathyroidism associated with chronic renal failure.

Zemplar (paricalcitol) Injection

Abbott Laboratories

NDA 20-819

4/17/98

5/6/98

5/8/98

6/19/01

Zerit XR (stavudine) Extended-Release Capsules, 37.5 mg, 50 mg, 75 mg, and 100 mg,

Bristol-Myers Squibb Company

NDA 21-453

12/31/02

1/30/03

4/9/03

ZERIT (stavudine) Capsules and Pediatric Oral Solution (POS).

Bristol-Myers Squibb Company

NDA 20-412/S15

10/16/01

4/22/03

ZERIT (stavudine) Capsules and Pediatric Oral Solution (POS),

Bristol-Myers Squibb Company

NDA 20-412/S16 & 20-413/S7

3/29/02

4/8/02

3/29/02

ZERIT (stavudine) Capsules and Pediatric Oral Solution (POS).

Bristol-Myers Squibb Company

NDA 20-412/S17, S18 & 20-413/S8, S9

2/20/02

2/21/02

ZERIT (stavudine) for Oral Solution

Bristol-Myers Squibb Company

NDA 20-413/S6

10/16/01

4/25/03

Zestoretic (lisinopril/hydrochlorothiazide) Tablets, 20/12.5, 20/25 and 10/12.5 mg, Rx

AstraZeneca Pharmaceuticals LP

NDA 19-888/S-035

4/17/03

Zestril (lisinopril) Tablet, 2.5, 5, 10, 20, 30 & 40 mg, Rx

AstraZeneca Pharmaceuticals

NDA 19-777/S-044/42

7/1/03

7/6/03

7/8/03

Zestril (lisinopril) Tablet, 2.5, 5, 10, 20, 30 & 40 mg, Rx

AstraZeneca Pharmaceuticals

NDA 19-777/S43

3/30/04

4/7/04

Zestril (lisinopril) Tablet, 2.5, 5, 10, 20, & 40 mg, Rx

Zeneca Pharmaceuticals

NDA 19-777/S-033

5/1/98

8//8/01

Zestril (lisinopril) Tablet, 2.5, 5, 10, 20, & 40 mg, Rx

Zeneca Pharmaceuticals

NDA 19-777/S-034

11/6/98

8//8/01

Zestril (lisinopril) Tablet, 2.5, 5, 10, 20, & 40 mg, Rx

Zeneca Pharmaceuticals

NDA 19-777/S-035

1/20/99

6/22/01

Zestril (lisinopril), Tablet/Oral, Rx

Zeneca Pharmaceuticals

NDA 19-777/S-037

2/7/00

2/14/00

Zestril Indications: This supplemental new drug application provides for changes in several sections of the package insert to incorporate statements concerning the use of high doses of lisinopril to reduce the risk of the combined outcomes of mortality and hospitalization in patients with congestive heart failure. These statements are based on the results of the "Assessment of Treatment with Lisinopril and Survival (ATLAS)" study.

Zetia (ezetimibe) Tablets, 10 mg, Rx

MSP Singapore Company, LLC

NDA 21-445

10/25/02

10/30/02

10/25/02

2/3/03

Ziac (bisoprolol fumarate and hydrochlorothiazide) Tablets and Zebeta (bisoprolol fumarate) Tablets, 2.5/6.25 mg, 5/6.25 mg, and 10/6.25 mg & 5 and 10 mg, respectively, Rx

Wyeth Pharmaceuticals

NDAs 20-186/S-015 and 19-982/S-010

1/24/03

1/27/03

Ziagen (abacavir sulfate) Tablets and Oral Solution,

GlaxoSmithKline

NDA 20-977/S11 & NDA 20-978/S13

4/15/04

Ziagen (abacavir sulfate) Tablets and Oral Solution,

GlaxoSmithKline

NDA 20-977/S10 & NDA 20-978/S12

7/17/03

7/28/03

9/25/03

Ziagen (abacavir sulfate) Tablets and Oral Solution,

GlaxoSmithKline

NDA 20-977/S8 & NDA 20-978/S10

8/14/02

8/21/02

8/14/02

Ziagen (abacavir sulfate) Tablets and Oral Solution,

GlaxoSmithKline

NDA 20-977/S7 & NDA 20-978/S8

10/2/02

10/11/01

10/3/02

Ziagen (abacavir sulfate) Tablets and Oral Solution,

GlaxoSmithKline

NDA 20-977/S5 & NDA 20-978/S6

1/28/02

3/6/02

Ziagen (abacavir sulfate) Tablets and Oral Solution,

Glaxo Wellcome Inc.

NDA 20-977/S2 & NDA 20-978/S2

12/15/00

4/14/04

Ziagen (abacavir sulfate) Tablets and Oral Solution,

Glaxo Wellcome Inc.

NDA 20-977 & NDA 20-978

12/17/98

1/6/99

4/4/02

Ziagen Indications: For the treatment of HIV-1 infection in adults and children (ages 3 months and above). This indication is based on analyses of surrogate markers in controlled studies up to 24 weeks in duration.

Zinacef (Cefuroxime for Injection and Dextrose Injection) USP, Rx

B. Braun Medical Inc.

NDA 50-780

2/21/01

Zinacef Indications: Lower respiratory tract infections, urinary tract infections, skin and skin structure infections, septicemia, meningitis, gonorrhea, and bone and joint infections (same as Zinacef).

Zinacef (Cefuroxime for Injection)

GlaxoSmithKline

NDA 50-558/S-050

10/12/01

5/2/03

Zinacef (Cefuroxime for Injection)

GlaxoSmithKline

NDA 50-643/S-

10/12/01

5/2/03

Zinc Chloride Injection, USP, Rx

Abbott Laboratories

NDA 18-959/S-008, S-011

2/14/03

2/25/03

ZINECARD (dexrazoxane) Injection, Rx

Pharmacia & Upjohn Company

NDA 20-212/S-004/S-005/S-006

10/31/02

11/18/02

11/1/02

Zithromax (azithromycin) Oral Suspension,

Pfizer Inc.

NDA 50-710/S19

4/27/04

Zithromax (azithromycin) Oral Suspension & Tablets,

Pfizer Inc.

NDA 50-710/S17/S21, 50-711/S15/S17

1/15/04

1/22/04

Zithromax (azithromycin) Oral Suspension & Tablets,

Pfizer Inc.

NDA 50-710/S20, 50-711/S16 & 50-784/S5

12/18/03

12/22/03

Zithromax (azithromycin) Tablets, 500 mg,

Pfizer Inc.

NDA 50-784/S4/S6

1/15/04

1/22/04

Zithromax TRI-PAK (azithromycin) Tablets, 500 mg,

Pfizer Inc.

NDA 50-784/S2

10/16/02

10/21/02

Zithromax TRI-PAK (azithromycin) Tablets, 500 mg,

Pfizer Inc.

NDA 50-784

5/24/02

6/3/02

10/22/02

Zithromax (Azithromycin) Oral Suspension, Rx

Pfizer Inc.

NDA 50-710/S-016

6/20/03

7/6/03

Zithromax (Azithromycin) Capsules, Single Dose Packet &Tablets, Rx

Pfizer Inc.

NDA 50-670/S22, 50-693/S9 & 50-730/S12

1/15/04

1/22/04

Zithromax (Azithromycin) Capsules, Single Dose Packet &Tablets, Rx

Pfizer Inc.

NDA 50-670/S21, 50-693/S8 & 50-730/S11

3/24/04

3/28/04

4/6/04

Zithromax (AzithromycinDihydrate) Capsules, Single Dose Packet, Oral Suspension, Tablets & IV, 250 & 600 (Mac) mg tablets, Rx

Pfizer Inc.

NDA 50-670/S19, 50-693/S7, 50-710/S-014, 50-711/S-012, 50-733/S-010 & 50-730/S10

7/22/02

7/24/02

Zithromax (Azithromycin) Capsules, Single Dose Packet & Tablets,

Pfizer Inc.

NDA 50-670/S17, 50-693/S5 & 50-730/S7

10/16/02

10/21/02

Zithromax (Azithromycin) Capsules, Single Dose Packet & Tablets

Pfizer Inc.

NDA 50-670/S15, 50-693/S3 & 50-730/S5

11/13/00

11/9/01

Zithromax (azithromycin tablets)

Pfizer, Inc.

NDA 50-710/S8

12/14/01

5/2/03

Zithromax (azithromycin tablets)

Pfizer, Inc.

NDA 50-710/S9

12/14/01

5/2/03

Zithromax (azithromycin for injection), I.V., Rx

Pfizer, Inc.

NDA 50-733/S-05

2/28/01

5/2/03

Zithromax (azithromycin) Injection, I.V., Rx

Pfizer, Inc.

NDA 50-733/S13

1/15/04

1/22/04

Zithromax (azithromycin) Injection, I.V., Rx

Pfizer, Inc.

NDA 50-733/S12

1/15/04

1/22/04

Zithromax (azithromycin for injection), I.V., Rx

Pfizer, Inc.

NDA 50-733/S-009

3/13/02

3/29/02

Zithromax (azithromycin for injection), I.V., Rx

Pfizer, Inc.

NDA 50-733/S-007

6/12/03

7/8/03

Zithromax (azithromycin for injection), I.V., Rx

Pfizer, Inc.

NDA 50-733/S-006

10/16/02

10/21/02

Zithromax (azithromycin) Oral Suspension and Tablets,

Pfizer Inc.

NDA 50-710/S7 & 50-711/S8

10/16/02

10/21/02

Zithromax (azithromycin) Pediatric Oral Suspension, and Zithromax (azithromycin)Tablets,

Pfizer Inc.

NDA 50-710/S11 & 50-711/S9

5/24/02

6/3/02

5/28/02

Zithromax (azithromycin) for Oral Suspension, Rx

Pfizer, Inc.

NDA 50-710/S-008/S-009

12/14/01

1/18/01

Zocor (Simvastatin) Tablets, Rx

Merck

NDA 19-766/S67 & S68

2/24/04

2/25/04

4/5/04

Zocor (Simvastatin) Tablets, Rx

Merck

NDA 19-766/S-027

3/31/98

5/6/98

4/30/02

Zocor (simvastatin) Tablets, Rx

Merck

NDA 19-766/
S-026, S-028

7/10/98

11/12/98

Zocor indication: These supplemental new drug applications provide for the use of a new dosage strength and dosing regimen (80 mg per day) of Zocor, (S-028) and for a new indication for the treatment of patients with homozygous familial hypercholesterolemia (S-026).

Zocor (simvastatin) Tablets, Rx

Merck

NDA 19-766/
S-029

6/29/98

10/23/98

Zocor (simvastatin) Tablets, Rx

Merck

NDA 19-766/
S-032

8/5/99

8/6/99

Zocor Indication (S32): This supplemental new drug application provides for the additional indication of increasing HDL-C in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Frederickson Types IIa and IIb). The revised first paragraph of the "Hyperlipidemia" subsection of INDICATIONS AND USAGE will state "Zocor is indicated as an adjunct to diet to reduce elevated total-C, LDL-C, Apo B, and TG levels, and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial andnonfamilial) and mixed dyslipidemia (Frederickson Types IIa and IIb)."

Zocor (simvastatin) Tablets, Rx

Merck

NDA 19-766/
S-034 & S-036

11/22/99

7/6/00,
7/6/00

Zocor (simvastatin) Tablets, Rx

Merck

NDA 19-766/
S-040

4/27/00

4/28/00

6/4/01

Zocor (simvastatin) Tablets, Rx

Merck

NDA 19-766/
S-042

11/7/00

Zocor (simvastatin) Tablets, Rx

Merck & Co., Inc.

NDA 19-766/S51

5/6/02

5/9/02

5/6/02

Zocor (simvastatin) Tablets, Rx

Merck & Co., Inc.

NDA 19-766/S52

3/21/02

3/29/02

3/21/02

7/5/02

Zocor (simvastatin) Tablets, Rx

Merck & Co., Inc.

NDA 19-766/S53

11/14/01

6/16/03

Zocor (simvastatin) Tablets, Rx

Merck & Co., Inc.

NDA 19-766/S56

10/18/02

10/28/02

10/18/02

Zocor (simvastatin) Tablets, Rx

Merck & Co., Inc.

NDA 19-766/S58

4/16/03

4/17/03

Zocor (simvastatin) Tablets, Rx

Merck & Co., Inc.

NDA 19-766/S65 & S66

9/17/03

9/29/03

9/25/03

Zofran & Zofran ODT (ondansetron) Tablets & Orally Disintegrating Tablets, Rx

GlaxoSmithKline

NDA 20-103/S-21 & 20-781/S-03

1/31/03

2/12/03

Zofran (ondansetron) Tablets, Rx

Glaxo Wellcome

NDA 20-103/S-018
20-605/S-005
20-718/S-002

12/13/00

2/20/01

Zofran (ondansetron) Tablets

Glaxo Wellcome

NDA 20-103/SE1-015

8/27/99

7/3/00

Zofran Indication: For the prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin.

Zofran ODT (odansetron) Orally Disintegrating Tablets

Glaxo Wellcome Inc.

NDA 20-781

1/27/99

5/23/01

Zofran indication: For prevention of chemotherapy and radiation-induced nausea and vomiting, and prevention of postoperative nausea and vomiting.

Zoladex (goserelin acetate) Implant, 3.6 & 10.8 mg

AstraZeneca Pharmaceuticals LP

NDA 19-726/S-037 & 20-578/S-016

2/28/02

3/5/02

Zoladex (goserelin acetate) Implant, 3-Month 10.8 mg Depot

AstraZeneca Pharmaceuticals LP

NDA 20-578/S13

2/5/02

4/17/02

Zoladex (goserelin acetate) Implant, 3.6 mg

AstraZeneca Pharmaceuticals LP

NDA 19-726/S-034

2/5/02

4/17/02

8/6/01

Zoladex (goserelin acetate) Implant, 3.6 mg

Zeneca Pharmaceuticals Inc.

NDA 19-726/S-022

4/9/98

8/6/01

Zoladex (goserelin acetate), 3.6 mg and 10.8 mg Depots

Zeneca

NDA 19-726/S-024 & 20-578/S-003

7/27/98

7/28/98

8/6/01

Zoladex indication: For the use of Zoladex (goserelin acetate) 3.6 mg and 10.8 mg Depots in combination with flutamide for the management of locally confined Stage T2b-T4 (Stage B2-C) cacinoma of the prostate.

Zoloft (sertraline hydrochloride) Tablets & Oral Concentrate, Rx

Pfizer, Inc.

NDA 19-839/S045 & 20-990/S011

2/7/03

2/12/03

2/13/03

Zoloft (sertraline hydrochloride) Tablets & Oral Concentrate, Rx

Pfizer

NDA 19-839/S44 & 20-990/S10

9/16/03

9/25/03

Zoloft (sertraline hydrochloride) Tablets & Oral Concentrate, Rx

Pfizer Pharmaceuticals

NDA 19-839/S043 & 20-990/S009

9/18/02

9/20/02

Zoloft (sertraline) Tablets & Oral Concentrate, Rx

Pfizer Inc.

NDA 19-839/S039 & 20-990/S007

5/16/02

5/21/02

5/16/02

Zoloft Indication: PMDD (Premenstrual Dysphoric Disorder).

Zoloft (sertraline hydrochloride) Tablets & Oral Concentrate,

Pfizer Pharmaceuticals

NDA 19-839/S036 & 20-990/S004

9/20/02

9/27/02

Zoloft (sertraline hydrochloride) Tablets & Oral Concentrate

Pfizer Pharmaceuticals, Inc.

NDA 19-839/S035 & 20-990/S003

8/17/01

11/6/01

11/7/01

Zoloft (sertraline hydrochloride) Tablets & Oral Concentrate

Pfizer Inc.

NDA 20-990/S-002 & S004

9/20/02

7/23/03

Zoloft (sertraline hydrochloride) Tablets & Oral Concentrate

Pfizer Inc.

NDA 19-839/S033 & 20-990/S-001

10/12/01

7/31/03

04/25/03

Zoloft (sertraline hydrochloride) Tablets

Pfizer Inc.

NDA 19-839/S026

12/7/99

7/26/01

Zoloft (sertraline hydrochloride) oral concentrate, 20 mg/ml

Pfizer Pharmaceuticals

NDA 20-990

12/7/99

12/28/99

5/29/01

Zoloft indication: depression, OCD, and panic disorder.

Zolpidem Tartrate Tablets, 5 & 10 mg, Rx Tentatively Approved

Mylan Pharmaceuticals

ANDA 76-578

7/17/03

Zolpidem Tartrate Tablets, 5 & 10 mg, Rx Tentatively Approved

Par Pharmaceutical, Inc.

ANDA 76-062

4/26/02

Zometa (zoledronic acid) Injection,

Novartis Pharmaceuticals Corporation

NDA 21-223/S8

3/24/04

3/28/04

4/6/04

Zometa (zoledronic acid) Injection,

Novartis Pharmaceuticals Corporation

NDA 21-223/S004

3/7/03

3/26/03

Zometa (zoledronic acid) Injection,

Novartis Pharmaceuticals Corporation

NDA 21-386S1 &
21-223/S6

2/27/04

3/3/04

Zometa (zoledronic acid) Injection,

Novartis Pharmaceuticals Corporation

NDA 21-386
NDA 21-223/S003

2/22/02

3/7/02

2/22/02

7/5/02

Zometa (zoledronic acid) Injection

Novartis Pharmaceuticals Corporation

NDA 21-223

8/20/01

11/5/01

11/8/01

Zomig (zolmitriptan) Nasal Spray,

AstraZeneca

NDA 21-450

9/30/03

10/10/03

Zomig (zolmitriptan) tablets,

AstraZeneca Pharmaceuticals LP

NDA 20-768/S-006

1/29/02

3/6/02

Zomig & Zomig-ZMT (zolmitriptan) Tablets, Rx

AstraZeneca Pharmaceuticals LP

NDA 20-768/S13 & 21-231/S5

1/8/04

1/14/04

Zomig (zolmitriptan) tablets & Zomig-ZMT (zolmitritpan) Orally Disintegrating Tablets, Rx

AstraZeneca Pharmaceuticals LP

NDA 20-768/S-010 & 21-231/S-03

10/9/02

10/21/02

Zomig-ZMT (zolmitritpan) Orally Disintegrating Tablets, Rx

AstraZeneca

NDA 21-231

2/13/01

3/30/01

Zomig Indications: Acute treatment of Migraine.

Zonalon (doxepin hydrochloride) Cream, 5%,

Bioglan Pharmaceuticals Company

NDA 20-126/S-006

12/20/02

1/29/03

4/4/03

Zonegran (zonisamide) Capsules, 100mg, Rx

Dainippon Pharmaceutical

NDA 20-789/S-5

10/7/02

10/11/01

10/8/02

Zonegran (zonisamide) Capsules, Rx

Dainippon Pharmaceutical

NDA 20-789/S1

8/22/03

8/28/03

Zonegran (zonisamide) Capsules, 100mg, Rx

Dainippon Pharmaceutical

NDA 20-789

3/27/00

3/31/00

5/1/02

Zaroxolyn & Mykrox (metolazone) Tablets,

Celltech Pharmaceuticals

NDA 17-386/S-036 & NDA 19-532/S-016

8/19/03

Zorbtive [Somatotropin (rDNA Origin)] Injection, Rx

Serono, Inc.

NDA 21-597 & 20-604/S26

12/1/03

12/4/03

12/8/03

Zosyn (Piperacillin Sodium & Tazobactam Sodium) Injection, in Galaxy Containers PL2040 Plastic

Wyeth Pharmaceuticals

NDA 50-750/S8

5/6/03

7/9/03

5/13/03

Zosyn (Piperacillin Sodium & Tazobactam Sodium) Injection, in Galaxy Containers PL2040 Plastic

Wyeth Pharmaceuticals

NDA 50-750/S7

5/6/03

7/9/03

5/13/03

Zosyn (Piperacillin Sodium & Tazobactam Sodium) Injection, in Galaxy Containers PL2040 Plastic

Lederle Piperacillin, Inc.

NDA 50-750

2/24/98

7/8/99

Zosyn (Piperacillin Sodium & Tazobactam Sodium) Injection, Rx

Wyeth Pharmaceuticals

NDA 50-684/S38

1/30/04

1/3/04

Zosyn (Piperacillin Sodium & Tazobactam Sodium) Injection, Rx

Wyeth Pharmaceuticals

NDA 50-684/S35

5/1/03

7/9/03

Zosyn (Piperacillin Sodium & Tazobactam Sodium) Injection, Rx

Wyeth Pharmaceuticals

NDA 50-684/S33

4/28/03

Zosyn (Sterile Piperacillin Sodium & Tazobactam Sodium) Injection, Rx

Wyeth-Ayerst Research

NDA 50-750/S3 & 50-684/S15

3/27/02

4/8/02

Zotrim (Sulfamethoxazole and Trimethoprim Tablets, USP and Phenazopyridine Hydrochloride) Tablets, USP

ABLE Laboratories Inc.

NDA 21-105

6/26/01

11/6/01

11/7/01

Zotrim Indication: Treatment of urinary tract infections and for the symptomatic relief of pain, burning, urgency, frequency, and other discomforts arising from irritation of the lower urinary tract mucosa caused by infection.

Zovirax

GlaxoSmithKline

NDA 18-828/S-026 & S-027

4/15/03

Zovirax (Acyclovir) Cream,

GlaxoSmithKline

NDA 21-478/S3

1/23/04

2/2/04

Zovirax (Acyclovir), Cream

GlaxoSmithKline

NDA 21-478

12/30/02

4/9/03

7/8/03

Zovirax (Acyclovir Sodium) Injection,

GlaxoSmithKline

NDA 18-603/S-023, S-024 & S-025

1/29/02

3/6/02

Zovirax (Acyclovir Sodium) for Injection, 10-mL and 20-mL vials

Glaxo Wellcome

NDA 18603/S-019

6/2/98

Zyban (bupropion hydrochloride) Sustained-Release Tablets,

GlaxoSmithKline

NDA 20-711/S13, S14, S16 & S18

2/14/03

2/25/03

Zyban (bupropion hydrochloride) extended-release tablets.

GlaxoSmithKline

NDA 20-711/S-015

2/21/02

Zyban (bupropion hydrochloride) Sustained-Release Tablets,

GlaxoSmithKline

NDA 20-711/S-012

2/7/01

5/30/02

Zyflo (zileutin tablets) Filmtab, Rx

Abbott Laboratories

NDA 20-471/S-009

12/16/02

1/29/03

Zyloprim (allopurinol) Tablets,

Prometheus Laboratories

NDA 16-084/S-041

7/17/02

8/6/02

Zymar (gatifloxacin) ophthalmic solution, 0.3%

Allergan, Inc.

NDA 21-493

3/28/03

4/1/03

Zyprexa IntraMuscular (olanzapine) Injection, Rx

Eli Lilly & Co.

NDA 21-253

3/29/04

4/7/04

4/6/04

Zyprexa (olanzapine) Tablets, Rx

Eli Lilly & Co.

NDA 20-592/S19

1/14/04

1/22/04

Zyprexa (olanzapine) Tablets, 2.5, 5, 7.5, 10, 15 & 20 mg, Rx

Eli Lilly & Co.

NDA 20-592/S18

7/10/03

7/28/03

7/10/03

Zyprexa Indications: Short-term treatment of acute manic episodes associated with Bipolar I Disorder, either as monotherapy (S-006) or in combination with lithium or valproate (S-018).

Zyprexa (olanzapine) Tablets, Rx

Eli Lilly & Co.

NDA 20-592/SE1-011

11/9/00

4/14/04

Zyprexa Zydis (olanzapine orally disintegrating) Tablets, Rx

Eli Lilly & Co.

NDA 21-086

4/6/00

4/13/00

7/31/01

Zyrtec (cetirizine hydrochloride) Tablets, Syrup & Extended-Release Tablets, Rx

Pfizer

NDA 19-835/S16, 21-150/S5 & 20-346/S11

3/17/04

3/23/04

4/7/04

Zyrtec (cetirizine hydrochloride) Tablets, 5 and 10 mg, and Syrup, 1mg/ml, Rx

Pfizer Pharmaceuticals

NDA 19-835/S-015 & 20-346/S-008

10/21/02

10/28/02

10/25/02

Zyrtec (cetirizine HCl) Tablets,

Pfizer

NDA 21-621

3/16/04

3/19/04

Zyrtec (cetirizine HCl) Tablets

Pfizer

NDA 19-835/S-005

5/15/98

5/22/01

Zyrtec (cetirizine HCl) Syrup

Pfizer

NDA 20-346/S-002

5/15/98

5/22/01

Zyrtec Indication: These supplements provide for the use of Zyrtec in pediatric patients 2 to 5 years of age for the indications seasonal and perennial allergic rhinitis and chronic idiopathic urticaria.

Zyrtec-D 12 hr. Extended-Release Tablets (Cetirizine Hydrochloride & Pseudoephedrine Hydroc