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
Gabapentin Capsules, 100, 300 & 400 mg, Rx Approvable	Eon Labs Manufacturing Inc.	ANDA 75-539	4/25/02
Gabapentin Capsules, 100, 300 & 400 mg, Rx Tentatively Approved	Ivax Pharmaceuticals, Inc.	ANDA 75-477	11/24/03
Gabapentin Capsules, 100, 300 & 400 mg, Rx Approvable	Ivax Pharmaceuticals, Inc.	ANDA 75-477	4/29/02
Gabapentin Capsules, 100, 300 & 400 mg, Rx Tentatively Approved	TEVA Pharmaceuticals	ANDA 75-435	8/7/03
Gabapentin Capsules, 100, 300 & 400 mg, Rx Approvable	TEVA Pharmaceuticals	ANDA 75-435	7/18/02
Gabapentin Capsules, 100, 300 & 400 mg, Rx Tentatively Approved	Geneva Pharmaceuticals	ANDA 75-428	12/10/03
Gabapentin Capsules, 100, 300 & 400 mg, Rx Tentatively Approved	TorPharm	ANDA 75-360	1/29/03
Gabapentin Capsules, 100, 300 & 400 mg, Rx	Purepac	ANDA 75-350	9/12/03
Gabapentin Capsules, 100, 300 & 400 mg, Rx Approvable	Purepac Pharmaceutical Co.	ANDA 75-350	4/25/02
Gabapentin Tablets, 100, 300 & 400mg, Rx, (600 & 800 mg Tentatively Approved)	Ivax Pharmaceuticals	ANDA 76-017	4/28/04	4/29/04
Gabapentin Tablets, 600 & 800 mg, Rx Tentatively Approved	Teva Pharmaceuticals	ANDA 75-827	10/17/03
Gabapentin Tablets, 600 & 800 mg, Rx Approvable	Purepac Pharmaceutical Co.	ANDA 75-694	7/29/02
Gallium Citrate Ga 67 Injection,	Bristol-Myers Squibb	NDA 17-478/S13	3/3/04	3/10/04
Galzin (Zinc Acetate) Capsules,	TEVA Pharmaceuticals USA	NDA 20-458/SLR-002	3/14/02	3/29/02
Ganciclovir Sodium Injection,	Bedford Laboratories	ANDA 76-222	7/16/03
Ganite (Gallium Nitrate) Injection,	Genta Inc.	NDA 19-961/S9	9/17/03	9/29/03
Gastrocrom (cromolyn sodium, USP) Oral Concentrate, Rx	Celltech Pharmaceuticals	NDA 20-479/S-005	2/13/03	2/25/03
Gemfibrozil Tablets USP, 600mg	Apotex	ANDA 75-034	7/20/98	7/20/98		9/25/02
Gemzar (gemcitabine HCl) for Injection, Rx	Eli Lilly	NDA 20-509/S21	5/1/02	5/9/02
Gemzar (gemcitabine HCl) for Injection, Rx	Eli Lilly	NDA 20-509/S13	1/6/03	1/23/03	1/23/03
Gemzar (gemcitabine HCl) for Injection, Rx	Eli Lilly	NDA 20-509 SE1-005	8/26/98	8/28/98	8/28/98
	Gemzar Indications: For use in combination with cisplatin for the first-line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB) or metastatic (Stage IV) non-small cell lung cancer.
Genotropin (somatropin [rDNA origin]) for injection, Rx	Pharmacia & Upjohn Company	NDA 20-280/S44	10/31/03	11/25/03
Genotropin (somatropin [rDNA origin] for injection), Rx	Pharmacia & Upjohn Company	NDA 20-280/S-040	5/12/03	7/9/03	7/9/03
Genotropin (somatropin [rDNA origin] for injection), 1.5, 5.8, and 13.8 mg, Rx	Pharmacia & Upjohn Company	NDA 20-280/S-038	3/28/03	4/15/03
Genotropin (somatropin [rDNA origin] ) Injection, Rx	Pharmacia & Upjohn Co.	NDA 20-280/S-023	6/20/00	7/24/00
	Genotropin Indication: For treatment of pediatric patients with Prader-Willi Syndrome.
Genotropin (somatropin [rDNA origin]) Injection), Rx	Pharmacia & Upjohn Co.	NDA 20-280/S-031	7/25/01	8/2/01	8/2/01	12/11/01
Gentamicin Sulfate Ophthalmic Solution USP, 0.3%, Rx	Altana, Inc.	ANDA 65-121	1/30/04
Gentamicin Sulfate Ophthalmic Solution USP, 0.3%, Rx	Akorn New Jersey, Inc.	ANDA 64-163	10/12/01	10/10/02
Geodon (Ziprasidone) Capsules & Injection, Rx	Pfizer, Inc.	NDA 20-825/S8 & 20-919/S1	12/23/03	12/24/03
Geodon (Ziprasidone) Capsules, Rx	Pfizer, Inc.	NDA 20-825/S6	2/15/02	3/8/02
Geodon (Ziprasidone HCI) Oral Capsules, Rx	Pfizer	NDA 20-825	2/5/01	2/12/01	2/12/01	1/7/02
	Geodon Indications: for the treatment of schizophrenia.
Geodon (Ziprasidone Mesylate) Injection, Rx	Pfizer, Inc.	NDA 20-919	6/21/02	6/24/02	6/21/02
Gleevec (imatinib mesylate) capsules, 100 mg, Rx	Novartis	NDA 21-335/S6	10/31/03	11/25/03
Gleevec (imatinib mesylate) capsules, 100 mg, Rx	Novartis Pharmaceuticals Corporation	NDA 21-335/S-004	12/20/02	1/29/03	12/23/02	7/8/03
Gleevec (imatinib mesylate) capsules, 50 mg and 100 mg, Rx	Novartis Pharmaceuticals Corporation	NDA 21-335/S-003	5/20/03	7/24/03
Gleevec (imatinib mesylate) capsules, 50 mg and 100 mg, Rx	Novartis Pharmaceuticals Corporation	NDA 21-335/S-001	2/1/02	2/1/02	2/1/02	7/8/03
	Gleevec Indication: This supplement added an indication for Gastrointestinal Stromal Tumors (GIST)
Gleevec (imatinib mesylate) capsules, 50 mg and 100 mg, Rx	Novartis Pharmaceuticals Corporation	NDA 21-335	5/10/01	5/11/01	5/11/01	10/17/01
	Gleevec Indication: for the treatment of patients with chronic myeloid leukemia (CML) in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy.
Gleevec (imatinib mesylate) Tablets, 100 and 400 mg, Rx	Novartis Pharmaceuticals Corporation	NDA 21-588/S002	12/8/03	12/22/03	12/8/03
Gleevec (imatinib mesylate) Tablets, 100 and 400 mg, Rx	Novartis Pharmaceuticals Corporation	NDA 21-588/S001	05/20/03	6/8/03	5/20/03
Gleevec (imatinib mesylate) Tablets, 100 and 400 mg, Rx	Novartis Pharmaceuticals Corporation	NDA 21-588	4/18/03
Gliadel Wafer (polifeprosan 20 with carmustine implant). Rx	Guilford Pharmaceuticals Inc.	NDA 20-637/S-016	2/25/03	3/10/03	2/25/03	7/8/03
Glipizide Extended-release Tablets, 10 mg, Rx	Watson Lab.	ANDA 76-467/S1	11/7/03
Glipizide Extended-release Tablets, 5 mg & 10 mg, Rx (5mg strength approved; 10mg strength is tentatively approved)	Watson Lab.	ANDA 76-467	9/8/03
Glipizide Extended-release Tablets, 10 mg, Rx Tentatively Approved	Andrx Pharmaceuticals	ANDA 76-159	8/22/03
Glipizide Tablets USP, 5 mg & 10 mg, Rx	TorPharm	ANDA 75-795	6/13/01	6/26/01
Glofil-125.	Questcor Pharmaceuticals, Inc.	NDA 17-279/S-008	1/22/02	2/5/02
GlucaGen [glucagon (rDNA origin) Injection, Rx	Novo Nordisk Pharmaceuticals	NDA 20-918/S8	3/1/04	3/3/04	4/5/04
GlucaGen [glucagon (rDNA origin) for Injection, Rx	Novo Nordisk Pharmaceuticals	NDA 20-918/S3	7/11/02	7/15/02
GlucaGen [glucagon (rDNA origin) for injection, SC, IM, or IV injection], Rx	Novo Nordisk Pharmaceuticals	NDA 20-918	6/22/98	6/24/98	6/24/98
	GlucaGen Indications: Treatment of hypoglycemia, and Use as a diagnostic aid.
Glucagon (rDNA origin) for Injection, Rx	Eli Lilly	NDA 20-928/S10	2/24/04	2/25/04	4/5/04
Glucagon (rDNA origin) for Injection, Rx	Eli Lilly	NDA 20-928	9/11/98	9/17/98	9/17/98	3/16/99
	Glucagon Indications:1) The treatment of severe hypoglycemia, and 2) Use as a diagnostic aid in the radiologic examination of the stomach, duodenum, small bowel, and colon when diminished intestinal motility would be advantageous. (Patient Information- 9/24/98)
Glucophage (metformin) Tablets(500 mg, 625 mg, 750 mg, 850 mg, 1000 mg), Rx	Bristol-Myers Squibb	NDA 20-357/S-010	10/22/98	10/26/98		7/2/99
	Glucophage Indication:This sNDA provided for the use of metformin and insulin in type 2 diabetes.
Glucophage (metformin) Tablets, (500 mg, 625 mg, 750 mg, 850 mg, 1000 mg), Rx	Bristol-Myers Squibb	NDA 20-357/S-017	9/22/99			7/6/00
Glucophage (Metformin Hydrochloride) Tablets, Rx	Bristol-Myers Squibb	NDA 20-357/S-019	12/15/00	2/20/01		8/17/01
	Glucophage Indication:Treatment of type 2 diabetes in pediatric patients (ages 10-16 years)
Glucophage� (metformin hydrochloride) Tablets, (500 mg, 850, and 1000 mg), Rx	Bristol-Myers Squibb	NDA 20-357/S-020	4/23/01	4/8/03
Glucophage XR (metformin HC1 extended-release) Tablets, (500 mg, 850 mg, 1000 mg), Rx	Bristol-Myers Squibb	NDA 21-202	10/13/00	10/20/00	10/20/00	2/3/03
Glucophage XR (metformin hydrochloride extended-release) Tablets, Rx	Bristol-Myers Squibb	NDA 21-202/S8	4/11/03	4/18/03	4/18/03
Glucophage XR (metformin hydrochloride extended-release) Tablets, 500 mg.	Bristol-Myers Squibb	NDA 21-202/S-001	4/19/01	5/1/01
Glucophage and Glucophage XR (metformin hydrochloride) Tablets & Extended-Release Tablets, Rx	Bristol-Myers Squibb	NDA 20-357/S26 & S27 & 21-202/S11 & S13	3/19/04	3/23/04	4/7/04
Glucophage (metformin hydrochloride)Tablets,Glucophage and Glucophage XR (metformin hydrochloride extended-release) Tablets, Rx	Bristol-Myers Squibb	NDA 21-202/S-003 & 20-357/S-024	1/8/02	2/8/02
Glucotrol XL (glipizide) Extended Release Tablets,	Pfizer Inc.	NDA 20-329/S15	9/17/03	9/29/03
Glucotrol XL (glipizide) Extended Release Tablets,	Pfizer Inc.	NDA 20-329/S-002	4/1/02	4/8/02	4/2/02
Glucovance (Glyburide and Metformin HCI) Tablets, Rx	Bristol-Myers Squibb	NDA 21-178/S7	3/15/04	3/17/04	4/6/04
Glucovance (Glyburide and Metformin HCL) Tablets, 1.25 mg/250 mg; 2.5 mg/500 mg; 5 mg/500 mg, Rx	Bristol-Myers Squibb	NDA 21-178/S-004	9/30/02	10/2/02	10/1/02	10/28/03
Glucovance (glyburide and metformin) Tablet, Rx	Bristol-Myers Squibb	NDA 21-178	7/31/00	8/4/00	8/4/00	12/30/03
	Glucovance Indications: 1. As initial therapy, as an adunct to diet and exercise, to improve glycemic control in patients with type 2 diabetes whose hyperglycemia cannot be satisfactorily managed with diet and exercise alone. 2. As second-line therapy when diet, exercise and initial treatment with a sulfonylurea or metformin do not result in adequate glycemic control in patients with type 2 diabetes.
Glyburide Tablets USP (Micronized), 1.5, 2.5 & 5 mg, Rx	CorePharma LLC	ANDA 76-257	6/27/02
Glyburide Tablets USP (Micronized), 1.5, 3 & 6 mg, Rx	Amide Pharmaceutical, Inc.	ANDA 75-947	11/14/02
Glyburide Tablets USP (Micronized), 1.5, 3 & 6 mg, Rx	Hikma Pharmaceuticals	ANDA 75-890	7/31/03
Glyburide Tablets USP (Micronized), 1.5, 3 & 6 mg, Rx, Tentatively Approved	Al-Hikma Pharmaceuticals	ANDA 75-890	2/8/02	4/10/03
Glyburide Tablets USP (Micronized), 1.5 mg and 3 mg	Invamed	ANDA 75-174	6/22/98	6/26/98
Glyburide Tablets (Micronized), 1.5 and 3 mg	Mylan Pharmacueticals	ANDA 74-792	6/26/98	7/6 /98
Glyburide Tablets USP (Micronized), 1.5 mg, 3 mg, 4.5 mg, and 6 mg, Rx	Novopharm Limited	ANDA 74-686	4/20/99	4/28/99
Glyburide & Metformin Hydrochloride Tablets, Rx	Ivax Pharmaceuticals	ANDA 76-345	2/18/04	2/27/04
Glycine Irrigation, USP, 1.5% in Plastic Container, PL 146	Baxter Healthcare Corporation	NDA 17-865/S-041	9/3/02	9/11/02
Glycine Irrigation, USP, 1.5% in Plastic Container, PL 146	Baxter Healthcare Corporation	NDA 17-865/S-040	9/3/02	9/11/02
Glycine Irrigation, USP, 1.5% in Plastic Container, PL 146	Baxter Healthcare Corporation	NDA 17-865/S-038	7/17/02	7/24/02
Glyset (Miglitol) Tablets, 25mg, 50mg, and 100mg, Rx	Pharmacia & Upjohn	NDA 20-682/S-001	8/16/99			5/19/00
	Glyset Indications: As an adjunct to diet to improve glycemic control in patients with non-insulin-dependent diabetes mellitus.
GoLYTELY (PEG-3350 and Electrolytes) for Oral Solution,	Braintree Laboratories, Inc.	NDA 19-011/S-015	9/19/02	9/24/02
Gonal-F (follitropin alfa) Injection, Rx	Serono, Inc.	NDA 20-378/S26 & S29	7/16/03	7/28/03
Gonal-F (follitropin alfa) Injection, Rx	Serono Inc.	NDA 20-378/S15	3/25/04	3/28/04	4/7/04
Gonal-F (follitropin alfa) Injection, Rx	Serono Laboratories	NDA 20-378/S-006	5/24/00	5/31/00		4/14/04
	Gonal-F Indications: for the induction of spermatogenesis in men with primary and secondary hopygonadotropic hypogonadism in whom the cause of infertility is not due to primary testicular failure.
Gris-PEG (Griseofulvin Ultramicrosize) Tablets, 125 & 250 mg, Rx	Pedinol Pharmacal, Inc.	NDA 50-475/S-046	3/26/03	4/15/03	4/1/03
Guanabenz Acetate Tablets USP, 4 mg (base) and 8 mg (base), Rx	Eon Labs Manufacturing	ANDA 74-517	9/30/98	9/30/98		8/4/03
Guanidine HCl Tablets, 125 mg	Schering Corporation	NDA 1-546/S-011	4/24/02	5/2/02
Gynazole 1 (butoconazole nitrate) Vaginal Cream, 2%	KV Pharmaceutical Company	NDA 19-881/S-009	7/24/03	8/6/03	8/6/03
Gyne Lotrimin 3	Schering Plough Healthcare Products	NDA 20-574	11/24/98	11/24/98	11/24/98	7/18/01
	GyneLotrimin 3 Indications: Treatment of vulvovaginal candidiasis.
Gynix Vaginal Tablets (Clotrimazole Vaginal Tablets, USP) 100mg	Copley Pharmaceutical, Inc.	ANDA 73-249	2/13/98			2/22/99

Product Name

Company

Application #

Approval
Date

Letter
Posted

Label
Posted

Review
Posted

Gabapentin Capsules, 100, 300 & 400 mg, Rx Approvable

Eon Labs Manufacturing Inc.

ANDA 75-539

4/25/02

Gabapentin Capsules, 100, 300 & 400 mg, Rx Tentatively Approved

Ivax Pharmaceuticals, Inc.

ANDA 75-477

11/24/03

Gabapentin Capsules, 100, 300 & 400 mg, Rx Approvable

Ivax Pharmaceuticals, Inc.

ANDA 75-477

4/29/02

Gabapentin Capsules, 100, 300 & 400 mg, Rx Tentatively Approved

TEVA Pharmaceuticals

ANDA 75-435

8/7/03

Gabapentin Capsules, 100, 300 & 400 mg, Rx Approvable

TEVA Pharmaceuticals

ANDA 75-435

7/18/02

Gabapentin Capsules, 100, 300 & 400 mg, Rx Tentatively Approved

Geneva Pharmaceuticals

ANDA 75-428

12/10/03

Gabapentin Capsules, 100, 300 & 400 mg, Rx Tentatively Approved

TorPharm

ANDA 75-360

1/29/03

Gabapentin Capsules, 100, 300 & 400 mg, Rx

Purepac

ANDA 75-350

9/12/03

Gabapentin Capsules, 100, 300 & 400 mg, Rx Approvable

Purepac Pharmaceutical Co.

ANDA 75-350

4/25/02

Gabapentin Tablets, 100, 300 & 400mg, Rx, (600 & 800 mg Tentatively Approved)

Ivax Pharmaceuticals

ANDA 76-017

4/28/04

4/29/04

Gabapentin Tablets, 600 & 800 mg, Rx Tentatively Approved

Teva Pharmaceuticals

ANDA 75-827

10/17/03

Gabapentin Tablets, 600 & 800 mg, Rx Approvable

Purepac Pharmaceutical Co.

ANDA 75-694

7/29/02

Gallium Citrate Ga 67 Injection,

Bristol-Myers Squibb

NDA 17-478/S13

3/3/04

3/10/04

Galzin (Zinc Acetate) Capsules,

TEVA Pharmaceuticals USA

NDA 20-458/SLR-002

3/14/02

3/29/02

Ganciclovir Sodium Injection,

Bedford Laboratories

ANDA 76-222

7/16/03

Ganite (Gallium Nitrate) Injection,

Genta Inc.

NDA 19-961/S9

9/17/03

9/29/03

Gastrocrom (cromolyn sodium, USP) Oral Concentrate, Rx

Celltech Pharmaceuticals

NDA 20-479/S-005

2/13/03

2/25/03

Gemfibrozil Tablets USP, 600mg

Apotex

ANDA 75-034

7/20/98

9/25/02

Gemzar (gemcitabine HCl) for Injection, Rx

Eli Lilly

NDA 20-509/S21

5/1/02

5/9/02

Gemzar (gemcitabine HCl) for Injection, Rx

Eli Lilly

NDA 20-509/S13

1/6/03

1/23/03

Gemzar (gemcitabine HCl) for Injection, Rx

Eli Lilly

NDA 20-509
SE1-005

8/26/98

8/28/98

Gemzar Indications: For use in combination with cisplatin for the first-line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB) or metastatic (Stage IV) non-small cell lung cancer.

Genotropin (somatropin [rDNA origin]) for injection, Rx

Pharmacia & Upjohn Company

NDA 20-280/S44

10/31/03

11/25/03

Genotropin (somatropin [rDNA origin] for injection), Rx

Pharmacia & Upjohn Company

NDA 20-280/S-040

5/12/03

7/9/03

Genotropin (somatropin [rDNA origin] for injection), 1.5, 5.8, and 13.8 mg, Rx

Pharmacia & Upjohn Company

NDA 20-280/S-038

3/28/03

4/15/03

Genotropin (somatropin [rDNA origin] ) Injection, Rx

Pharmacia & Upjohn Co.

NDA 20-280/S-023

6/20/00

7/24/00

Genotropin Indication: For treatment of pediatric patients with Prader-Willi Syndrome.

Genotropin (somatropin [rDNA origin]) Injection), Rx

Pharmacia & Upjohn Co.

NDA 20-280/S-031

7/25/01

8/2/01

12/11/01

Gentamicin Sulfate Ophthalmic Solution USP, 0.3%, Rx

Altana, Inc.

ANDA 65-121

1/30/04

Gentamicin Sulfate Ophthalmic Solution USP, 0.3%, Rx

Akorn New Jersey, Inc.

ANDA 64-163

10/12/01

10/10/02

Geodon (Ziprasidone) Capsules & Injection, Rx

Pfizer, Inc.

NDA 20-825/S8 & 20-919/S1

12/23/03

12/24/03

Geodon (Ziprasidone) Capsules, Rx

Pfizer, Inc.

NDA 20-825/S6

2/15/02

3/8/02

Geodon (Ziprasidone HCI) Oral Capsules, Rx

Pfizer

NDA 20-825

2/5/01

2/12/01

1/7/02

Geodon Indications: for the treatment of schizophrenia.

Geodon (Ziprasidone Mesylate) Injection, Rx

Pfizer, Inc.

NDA 20-919

6/21/02

6/24/02

6/21/02

Gleevec (imatinib mesylate) capsules, 100 mg, Rx

Novartis

NDA 21-335/S6

10/31/03

11/25/03

Gleevec (imatinib mesylate) capsules, 100 mg, Rx

Novartis Pharmaceuticals Corporation

NDA 21-335/S-004

12/20/02

1/29/03

12/23/02

7/8/03

Gleevec (imatinib mesylate) capsules, 50 mg and 100 mg, Rx

Novartis Pharmaceuticals Corporation

NDA 21-335/S-003

5/20/03

7/24/03

Gleevec (imatinib mesylate) capsules, 50 mg and 100 mg, Rx

Novartis Pharmaceuticals Corporation

NDA 21-335/S-001

2/1/02

7/8/03

Gleevec Indication: This supplement added an indication for Gastrointestinal Stromal Tumors (GIST)

Gleevec (imatinib mesylate) capsules, 50 mg and 100 mg, Rx

Novartis Pharmaceuticals Corporation

NDA 21-335

5/10/01

5/11/01

10/17/01

Gleevec Indication: for the treatment of patients with chronic myeloid leukemia (CML) in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy.

Gleevec (imatinib mesylate) Tablets, 100 and 400 mg, Rx

Novartis Pharmaceuticals Corporation

NDA 21-588/S002

12/8/03

12/22/03

12/8/03

Gleevec (imatinib mesylate) Tablets, 100 and 400 mg, Rx

Novartis Pharmaceuticals Corporation

NDA 21-588/S001

05/20/03

6/8/03

5/20/03

Gleevec (imatinib mesylate) Tablets, 100 and 400 mg, Rx

Novartis Pharmaceuticals Corporation

NDA 21-588

4/18/03

Gliadel Wafer (polifeprosan 20 with carmustine implant). Rx

Guilford Pharmaceuticals Inc.

NDA 20-637/S-016

2/25/03

3/10/03

2/25/03

7/8/03

Glipizide Extended-release Tablets, 10 mg, Rx

Watson Lab.

ANDA 76-467/S1

11/7/03

Glipizide Extended-release Tablets, 5 mg & 10 mg, Rx
(5mg strength approved; 10mg strength is tentatively approved)

Watson Lab.

ANDA 76-467

9/8/03

Glipizide Extended-release Tablets, 10 mg, Rx Tentatively Approved

Andrx Pharmaceuticals

ANDA 76-159

8/22/03

Glipizide Tablets USP, 5 mg & 10 mg, Rx

TorPharm

ANDA 75-795

6/13/01

6/26/01

Glofil-125.

Questcor Pharmaceuticals, Inc.

NDA 17-279/S-008

1/22/02

2/5/02

GlucaGen [glucagon (rDNA origin) Injection, Rx

Novo Nordisk Pharmaceuticals

NDA 20-918/S8

3/1/04

3/3/04

4/5/04

GlucaGen [glucagon (rDNA origin) for Injection, Rx

Novo Nordisk Pharmaceuticals

NDA 20-918/S3

7/11/02

7/15/02

GlucaGen [glucagon (rDNA origin) for injection, SC, IM, or IV injection], Rx

Novo Nordisk Pharmaceuticals

NDA 20-918

6/22/98

6/24/98

GlucaGen Indications: Treatment of hypoglycemia, and Use as a diagnostic aid.

Glucagon (rDNA origin) for Injection, Rx

Eli Lilly

NDA 20-928/S10

2/24/04

2/25/04

4/5/04

Glucagon (rDNA origin) for Injection, Rx

Eli Lilly

NDA 20-928

9/11/98

9/17/98

3/16/99

Glucagon Indications:1) The treatment of severe hypoglycemia, and 2) Use as a diagnostic aid in the radiologic examination of the stomach, duodenum, small bowel, and colon when diminished intestinal motility would be advantageous. (Patient Information- 9/24/98)

Glucophage (metformin) Tablets(500 mg, 625 mg, 750 mg, 850 mg, 1000 mg), Rx

Bristol-Myers Squibb

NDA 20-357/S-010

10/22/98

10/26/98

7/2/99

Glucophage Indication:This sNDA provided for the use of metformin and insulin in type 2 diabetes.

Glucophage (metformin) Tablets, (500 mg, 625 mg, 750 mg, 850 mg, 1000 mg), Rx

Bristol-Myers Squibb

NDA 20-357/S-017

9/22/99

7/6/00

Glucophage (Metformin Hydrochloride) Tablets, Rx

Bristol-Myers Squibb

NDA 20-357/S-019

12/15/00

2/20/01

8/17/01

Glucophage Indication:Treatment of type 2 diabetes in pediatric patients (ages 10-16 years)

Glucophage� (metformin hydrochloride) Tablets, (500 mg, 850, and 1000 mg), Rx

Bristol-Myers Squibb

NDA 20-357/S-020

4/23/01

4/8/03

Glucophage XR (metformin HC1 extended-release) Tablets, (500 mg, 850 mg, 1000 mg), Rx

Bristol-Myers Squibb

NDA 21-202

10/13/00

10/20/00

2/3/03

Glucophage XR (metformin hydrochloride extended-release) Tablets, Rx

Bristol-Myers Squibb

NDA 21-202/S8

4/11/03

4/18/03

Glucophage XR (metformin hydrochloride extended-release) Tablets, 500 mg.

Bristol-Myers Squibb

NDA 21-202/S-001

4/19/01

5/1/01

Glucophage and Glucophage XR (metformin hydrochloride) Tablets & Extended-Release Tablets, Rx

Bristol-Myers Squibb

NDA 20-357/S26 & S27 & 21-202/S11 & S13

3/19/04

3/23/04

4/7/04

Glucophage (metformin hydrochloride)Tablets,Glucophage and Glucophage XR (metformin hydrochloride extended-release) Tablets, Rx

Bristol-Myers Squibb

NDA 21-202/S-003 & 20-357/S-024

1/8/02

2/8/02

Glucotrol XL (glipizide) Extended Release Tablets,

Pfizer Inc.

NDA 20-329/S15

9/17/03

9/29/03

Glucotrol XL (glipizide) Extended Release Tablets,

Pfizer Inc.

NDA 20-329/S-002

4/1/02

4/8/02

4/2/02

Glucovance (Glyburide and Metformin HCI) Tablets, Rx

Bristol-Myers Squibb

NDA 21-178/S7

3/15/04

3/17/04

4/6/04

Glucovance (Glyburide and Metformin HCL) Tablets, 1.25 mg/250 mg; 2.5 mg/500 mg; 5 mg/500 mg, Rx

Bristol-Myers Squibb

NDA 21-178/S-004

9/30/02

10/2/02

10/1/02

10/28/03

Glucovance (glyburide and metformin) Tablet, Rx

Bristol-Myers Squibb

NDA 21-178

7/31/00

8/4/00

12/30/03

Glucovance Indications: 1. As initial therapy, as an adunct to diet and exercise, to improve glycemic control in patients with type 2 diabetes whose hyperglycemia cannot be satisfactorily managed with diet and exercise alone.
2. As second-line therapy when diet, exercise and initial treatment with a sulfonylurea or metformin do not result in adequate glycemic control in patients with type 2 diabetes.

Glyburide Tablets USP (Micronized), 1.5, 2.5 & 5 mg, Rx

CorePharma LLC

ANDA 76-257

6/27/02

Glyburide Tablets USP (Micronized), 1.5, 3 & 6 mg, Rx

Amide Pharmaceutical, Inc.

ANDA 75-947

11/14/02

Glyburide Tablets USP (Micronized), 1.5, 3 & 6 mg, Rx

Hikma Pharmaceuticals

ANDA 75-890

7/31/03

Glyburide Tablets USP (Micronized), 1.5, 3 & 6 mg, Rx, Tentatively Approved

Al-Hikma Pharmaceuticals

ANDA 75-890

2/8/02

4/10/03

Glyburide Tablets USP (Micronized), 1.5 mg and 3 mg

Invamed

ANDA 75-174

6/22/98

6/26/98

Glyburide Tablets (Micronized), 1.5 and 3 mg

Mylan Pharmacueticals

ANDA 74-792

6/26/98

7/6 /98

Glyburide Tablets USP (Micronized), 1.5 mg, 3 mg, 4.5 mg, and 6 mg, Rx

Novopharm Limited

ANDA 74-686

4/20/99

4/28/99

Glyburide & Metformin Hydrochloride Tablets, Rx

Ivax Pharmaceuticals

ANDA 76-345

2/18/04

2/27/04

Glycine Irrigation, USP, 1.5% in Plastic Container, PL 146

Baxter Healthcare Corporation

NDA 17-865/S-041

9/3/02

9/11/02

Glycine Irrigation, USP, 1.5% in Plastic Container, PL 146

Baxter Healthcare Corporation

NDA 17-865/S-040

9/3/02

9/11/02

Glycine Irrigation, USP, 1.5% in Plastic Container, PL 146

Baxter Healthcare Corporation

NDA 17-865/S-038

7/17/02

7/24/02

Glyset (Miglitol) Tablets, 25mg, 50mg, and 100mg, Rx

Pharmacia & Upjohn

NDA 20-682/S-001

8/16/99

5/19/00

Glyset Indications: As an adjunct to diet to improve glycemic control in patients with non-insulin-dependent diabetes mellitus.

GoLYTELY (PEG-3350 and Electrolytes) for Oral Solution,

Braintree Laboratories, Inc.

NDA 19-011/S-015

9/19/02

9/24/02

Gonal-F (follitropin alfa) Injection, Rx

Serono, Inc.

NDA 20-378/S26 & S29

7/16/03

7/28/03

Gonal-F (follitropin alfa) Injection, Rx

Serono Inc.

NDA 20-378/S15

3/25/04

3/28/04

4/7/04

Gonal-F (follitropin alfa) Injection, Rx

Serono Laboratories

NDA 20-378/S-006

5/24/00

5/31/00

4/14/04

Gonal-F Indications: for the induction of spermatogenesis in men with primary and secondary hopygonadotropic hypogonadism in whom the cause of infertility is not due to primary testicular failure.

Gris-PEG (Griseofulvin Ultramicrosize) Tablets, 125 & 250 mg, Rx

Pedinol Pharmacal, Inc.

NDA 50-475/S-046

3/26/03

4/15/03

4/1/03

Guanabenz Acetate Tablets USP, 4 mg (base) and 8 mg (base), Rx

Eon Labs Manufacturing

ANDA 74-517

9/30/98

8/4/03

Guanidine HCl Tablets, 125 mg

Schering Corporation

NDA 1-546/S-011

4/24/02

5/2/02

Gynazole 1 (butoconazole nitrate) Vaginal Cream, 2%

KV Pharmaceutical Company

NDA 19-881/S-009

7/24/03

8/6/03

Gyne Lotrimin 3

Schering Plough Healthcare Products

NDA 20-574

11/24/98

7/18/01

GyneLotrimin 3 Indications: Treatment of vulvovaginal candidiasis.

Gynix Vaginal Tablets (Clotrimazole Vaginal Tablets, USP) 100mg

Copley Pharmaceutical, Inc.

ANDA 73-249

2/13/98

2/22/99

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