|
New! As of May 1, 2004, New and Generic Drug Approvals 1998-2004,
will not be updated. |
| Product Name | Company | Application # |
Approval
Date |
Letter
|
Label
Posted |
Review
Posted |
|---|---|---|---|---|---|---|
| Labetalol Hydrochloride Injection USP, 5 mg/mL, 4mL, 8 mL, 20 mL & 40 mL vials, Rx | Apotex Corp. | ANDA 76-051 | 7/5/02 | |||
| Labetalol Hydrochloride Injection USP, 5 mg/mL (20 mL & 40 mL vials). | Bedford Laboratorie | ANDA 75-303 | 5/28/99 | 6/1/99 | ||
| Labetalol Hydrochloride Tablets USP, 100 mg, 200 mg, 300 mg, Rx | Mutual Pharmaceutical Company, Inc. | ANDA 75-215 | 7/29/99 | 7/29/99 | ||
| Labetalol Hydrochloride Injection USP, 5 mg/mL (Multiple-Dose Vials) | Faulding Pharmaceutical Co. | ANDA 75-242 | 9/30/99 | 10/4/99 | ||
| Labetalol Hydrochloride Injection USP, 5 mg/mL (Multiple-Dose Vials) Tentatively Approved 12/29/1998 | Faulding Pharmaceutical Co. | ANDA 75-242 | 12/29/98 | 12/29/98 | ||
| Labetalol Hydrochloride Injection USP, 5 mg/mL (Carpuject) Tentatively Approved 11/27/1998 | Abbott Laboratories | ANDA 75-239 | 11/27/98 | 11/27/98 | ||
| Labetalol Hydrochloride Injection USP, 5 mg/mL (Carpuject) | Abbott Laboratories | ANDA 75-239 | 11/29/99 | 12/29/99 | ||
| Labetalol Hydrochloride Injection USP, 5 mg/mL (Multiple Dose Vials) Tentatively Approved 11/27/1998 | Abbott Laboratories | ANDA 75-240 | 11/27/98 | 11/27/98 | ||
| Labetalol Hydrochloride Injection USP, 5 mg/mL (Multiple Dose Vials) | Abbott Laboratories | ANDA 75-240 | 11/29/99 | 12/29/99 | ||
|
Labetalol Hydrochloride Injection USP, 5mg/mL, Rx, Tentatively Approved 2/23/1999 |
Apothecon, Inc. | ANDA 75-355 | 2/23/99 | 3/04/99 | ||
| Labetalol Hydrochloride Injection USP, 5mg/mL, Rx | Apothecon, Inc. | ANDA 75-355 | 11/29/99 | 12/29/99 | ||
| Labetalol Hydrochloride Injection USP, 5mg/mL, Rx | Taylor Pharmaceuticals | ANDA 75-431 | 12/29/99 | 12/29/99 | ||
| Labetalol Hydrochloride Injection USP, 5mg/mL, Rx | Taylor Pharmaceuticals | ANDA 75-524 | 11/29/99 | 12/29/99 | ||
| Labetalol Hydrochloride Tablets USP, 100 mg, 200 mg, and 300 mg, Rx | Apothecon, Inc. | ANDA 75-223 | 11/23/98 | 11/23/98 | ||
| Labetalol Hydrochloride Tablets USP, 100 mg, 200 mg, and 300 mg, Rx | Eon Laboratories Manufacturing | ANDA 75-113 | 8/4/98 | 9/8/98 | ||
| Labetalol Hydrochloride Tablets USP, 100 mg, 200 mg, 300 mg, Rx | TEVA Pharmaceuticals USA | ANDA 74-989 | 9/30/98 | 9/30/98 | 9/25/02 | |
| Labetalol Hydrochloride Tablets USP, 100 mg, 200 mg, 300 mg, Rx | Watson Laboratories | ANDA 75-133 | 8/3/98 | 8/7/98 | 9/25/02 | |
| Labetalol Hydrochloride Tablets USP, 100 mg, 200 mg and 300 mg, Rx | Zenith Goldline Pharmaceuticals | ANDA 74-787 | 8/3/98 | 8/5/98 | 8/5/03 | |
| Lac-Hydrin Cream, 12%, Rx | Westwood Squibb | NDA 20-508/S-005 | 8/25/00 | 10/20/00 | 10/20/00 | 12/11/01 |
| Lac-Hydrin Indication: Treatment of ichthyosis and xerosis. | ||||||
| Lac-Hydrin Lotion, 12%, Rx | Bristol-Myers Squibb | NDA 20-508/S19 & S20 | 4/29/04 | |||
| Lacrisert (Hydroxypropyl Cellulose Ophthalmic Insert) Sterile, | Merck & Co., Inc. | NDA 18-771/S12 | 3/20/02 | 3/29/02 | 3/21/02 | |
| Lactated Ringer’s Injection, | Baxter Healthcare Corporation | NDA 16-682/S-096 | 6/27/03 | 7/6/03 | ||
| Lactulose Solution USP, 10 g/15 mL, Rx | Novex Pharma | ANDA 76-645 | 7/28/03 | |||
| Lactulose Solution USP, 10 g/15 mL, Rx | Novex Pharma | ANDA 75-911 | 2/21/02 | 4/10/03 | ||
| Lactulose Oral Solution, 10 g/5 mL, Rx | Vintage Pharmaceuticals, Inc. | ANDA 75-993 | 7/23/01 | |||
| Lamictal (lamotrigine) Tablets, Rx | SmithKline Beecham | NDA 20-241/S-018 | 4/4/03 | 4/18/03 | ||
| Lamictal (lamotrigine) Tablets & Chewable Dispersible Tablets, Rx | GlaxoSmithKline | NDA 20-241/S-017 & 20-764/S-011 | 6/20/03 | 7/6/03 | 7/8/03 | |
| Lamictal (lamotrigine) Tablets & Chewable Dispersible Tablets, Rx | GlaxoSmithKline | NDA 20-241/S16 & 20-764/S9 | 1/14/04 | 1/22/04 | ||
| Lamictal (lamotrigine) Tablets & Chewable Dispersible Tablets, 25, 100, 150 and 200mg & 2.5 and 25 mg, Rx | Glaxo Wellcome | NDA 20-241/S-008 & 20-764/S-002 | 1/17/03 | 1/23/03 | ||
| Lamictal (lamotrigine) Chewable Dispersible Tablets, Rx,Dear Health Professional Letter | Glaxo Wellcome | NDA 20-764 | 8/24/98 | 8/24/98 | 8/24/98 | 5/20/99 |
| Lamictal Indications: This application provides bioequivalency data to support a new dosage form of lamotrigine, and clinical data to support a new indication for the use of lamotrigine, as compared to the already approved Lamictal Tablet. Specifically, the new indication is for the use of lamotrigine for adjunctive treatment of Lennox-Gastaut syndrome in pediatric and adult patients. | ||||||
| Lamictal (lamotrigine) Tablets, Rx,Dear Health Professional Letter | Glaxo Wellcome | NDA 20-241/ S-002: |
8/24/98 | 8/24/98 | 8/24/98 | 5/20/99 |
| Lamictal Indications: This application (NDA 20-241/S-002), an efficacy supplement, incorporates by reference the clinical data contained in the Lamictal CD Chewable Tablet application (NDA 20-764) so that the approved compressed tablet formulation can gain the new indication, as well. This cross-reference also allows for the development of one label for both lamotrigine products. | ||||||
|
Lamictal (lamotrigine) Tablets&
Lamictal (lamotrigine)
Chewable Dispersible Tablets, Rx,Dear Health Professional Letter |
Glaxo Wellcome | NDA 20-241/S-003 & NDA 20-764/S-001 | 12/14/98 | 12/15/98 | 12/15/98 | 6/30/99 |
| Lamictal Indications: These efficacy supplements provide for the use of Lamictal as conversion to monotherapy in adults with partial seizures who are receiving treatment with a single enzyme-inducing antiepileptic drug (EIAED). | ||||||
Lamictal Tablets and Lamictal Chewable Dispersible Tablets , Rx |
Glaxo Wellcome | NDA 20-241/S-011 & NDA 20-764/S-005: | 5/25/01 | 5/29/01 | ||
| Lamictal Indication: Application provides for: clinical data in support of a labeling revision to update the Geriatric Use subsection of the Lamictal package insert. | ||||||
| Lamisil (terbinafine gel) DermGel, 1%, Rx, Dear Health Professional Letter | Novartis Pharmaceutical Corporation | NDA 20-846/S-001 | 7/26/99 | 8/4/99 | 8/4/99 | |
| Lamisil Indication: for Tinea | ||||||
| Lamisil/terbinafine Dermgel, 1%,Dear Health Professional Letter | Novartis | NDA 20-846 | 4/29/98 | 5/6/98 | 5/8/98 | 2/4/99 |
| Lamisil (terbinafine Hydrochloride) Cream, 1% , Rx to OTC switch, Dear Health Professional Letter | Novartis | NDA 20-980 | 3/10/99 | 6/28/99 | ||
| Lamisil Cream Indications: Application provides for use without prescription of Lamisil (terbinafine hydrochloride cream) Cream, 1%, for the treatment of tinea pedis (athlete's foot), tinea cruris (jock itch) and tinea corporis (ringworm), due to Epidermophyton floccosum, Trichophyton mentagrophytes and Trichophyton rubrum. | ||||||
| Lamisil AT (terbinafine hydrochloride) Spray Pump Solution, 1%, Dear Health Professional Letter | Novartis Consumer Health, Inc. | NDA 21-124 | 3/17/00 | 3/31/00 | 3/31/00 | 5/15/02 |
| Lamisil (terbinafine hydrochloride solution) Solution, 1%, | Novartis Consumer Health, Inc. | NDA 20-749/S-004 | 3/27/03 | 4/15/03 | 4/1/03 | |
| Lamisil (terbinafine hydrochloride) Tablets, | Novartis Pharmaceuticals Corporation | NDA 20-539/S12 | 1/21/04 | 2/2/04 | 2/2/04 | |
| Lamisil (terbinafine hydrochloride) Tablets | Novartis Pharmaceuticals Corporation | NDA 20-539/S-010 | 4/13/01 | 5/3/01 | ||
| Lamprene (clofazimine) Capsules, | Novartis Pharmaceuticals Corporation | NDA 19-500/S-010 | 6/11/03 | 7/8/03 | 7/8/03 | |
| Lanoxin (digoxin) Injection, 0.25 mg/mL, | GlaxoSmithKline | NDA 9-330/S-021 | 6/17/02 | 6/18/02 | ||
| Lanoxin (Digoxin) Injection & Pediatric Injection & Lanoxicaps (Digoxin In Solution) Capsules | Glaxo Wellcome, Inc. | NDA 9-330/S020 & 18-118/S016 | 7/15/98 | 9/14/01 | ||
| Lantus (insulin glargine [rDNA origin] injection), Rx. | Aventis Pharmaceuticals | NDA 21-081/S5 | 5/1/03 | 7/9/03 | 7/9/03 | |
| Lantus (insulin glargine [rDNA origin] injection), Rx. | Aventis Pharmaceuticals | NDA 21-081 | 4/20/00 | 4/24/00 | 4/24/00 | 3/18/02 |
| Lantus Indication: is indicated for once-daily subcutaneous administration at bedtime in the treatment of adult and pediatric patients with type 1 diabetes mellitus or adult patients with type 2 diabetes mellitus who require basal (long-acting) insulin for the control of hyperglycemia. | ||||||
| Lariam (mefloquine hydrochloride) Tablets, 250 mg | Hoffman-LaRoche, Inc. | NDA 19-591/S-022 | 8/20/03 | 8/28/03 | 8/28/03 | |
| Lariam (mefloquine hydrochloride) Tablets, 250 mg | Hoffman-LaRoche, Inc. | NDA 19-591/S-020 | 10/3/02 | 10/4/02 | ||
| Lariam (mefloquine hydrochloride) Tablets, 250 mg | Hoffman-LaRoche, Inc. | NDA 19-591/S-019 | 7/9/03 | 7/10/03 | 7/9/03 | |
| Lariam (mefloquine hydrochloride) Tablets, 250 mg | Hoffman-LaRoche, Inc. | NDA 19-591/S-14/17 | 1/10/03 | 1/15/03 | 1/15/03 | |
| Lente Iletin® II Pork (insulin zinc suspension, USP purified pork), | Eli Lilly and Company | NDA 18-347/S-025 | 10/10/03 | 10/16/03 | 10/16/03 | |
| Lescol Capsules & Lescol XL (fluvastatin sodium) Extended release Tablets, Rx | Novartis Pharmaceutical Corporation | NDA 20-261/S32 & 21-192/S4 | 9/6/02 | 9/11/02 | 9/6/02 | |
| Lescol XL (fluvastatin sodium) Extended release Tablets, Rx | Novartis Pharmaceutical Corporation | NDA 21-192 & 20261/S28 | 10/6/00 | 10/20/00 | 3/24/04 | |
| Lescol XL (fluvastatin sodium) Extended release Tablets, Rx | Novartis Pharmaceutical Corporation | NDA 21-192/S2 | 9/25/01 | 5/1/03 | ||
| Lescol (fluvastatin sodium) capsules, Rx | Novartis Pharmaceutical Corporation | NDA 20-261/S-018 & S-022 | 3/8/99 | 6/3/99 | ||
|
Lescol
Supplement-018provides for a new indication, the reduction of triglycerides and ApoB in patients with
primary hypercholesterolemia and mixed dyslipidemia Lescol Supplement-022provides for a reduction in the recommended frequency of Liver Function Testing (LFT) and eliminates periodic, i.e., semi-annual, LFT monitoring |
||||||
| Lescol (fluvastatin sodium) Capsules, Rx | Novartis Pharmaceutical Corporation | NDA 20-261/S-024 | 10/23/00 | 11/27/00 | 11/27/00 | |
| Lescol Supplement-024 as an adjunct to diet to reduce elevated total cholesterol (total-C), LDL-C, TG, and Apo B levels, and to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia (Frederickson Type IIa and IIb) whose response to dietary restriction of saturated fat and cholesterol and other nonpharmacological measures has not been adequate | ||||||
| Lescol (fluvastatin) Capsules, Rx | Novartis Pharmaceutical Corporation | NDA 20-261/S-025 | 12/19/00 | 2/20/01 | ||
| Lescol (fluvastatin) Capsules, Rx | Novartis Pharmaceutical Corporation | NDA 20-261/S-30 | 9/25/01 | 4/23/03 | ||
| Lessina-21 & Lessina-28 (Levonorgestrel & Ethinyl Estradiol) Tablets USP, 0.1 & 0.02 mg, Rx | Barr Laboratories, Inc. | ANDA 75-803 | 3/20/02 | 4/10/03 | 12/24/03 | |
| Leucovorin Calcium Injection, | Mayne | NDA 8-107/S-055 | 12/16/03 | 12/22/03 | ||
| Leucovorin Calcium Injection | Xanodyne Pharmacal, Inc. | NDA 8-107/S-054 | 2/12/02 | 3/7/02 | ||
| Leucovorin Calcium Injection USP, 10 mg (base)/mL, 300 mg (base)/30 mL, & 500 mg (50 mL) single dose vials, Rx | Bedford Laboratories | ANDA 40-347 | 4/25/00 | 4/28/00 | 8/4/03 | |
Leucovorin Calcium for Injection (Preservative-free), 50 mg (base)/vial, Rx |
Luitpold Pharmaceuticals, Inc. | ANDA 40-338 | 1/31/01 | 2/27/01 | ||
Leucovorin Calcium for Injection (Preservative-free), 350 mg (base)/vial, Rx |
Bedford Laboratories | ANDA 40-335 | 4/20/00 | 4/24/00 | ||
| Leucovorin Calcium Injection USP, 10 mg (base)/mL, 500 mg (50 mL) single dose vial | Gensia Sicor | ANDA 40-332 | 6/28/99 | 7/2/99 | ||
| Leucovorin Calcium for Injection, 500 mg (base)/vial | Bigmar, Inc. | ANDA 40-286 | 2/26/99 | 3/2/99 | 1/17/02 | |
| Leucovorin Calcium for Injection, 350 mg (base)/vial. | TEVA U.S.A., Inc. | ANDA 40-262 | 12/15/99 | 12/27/99 | 8/4/03 | |
| Leucovorin Calcium for Injection, 200 mg (base)/vial | Bigmar, Inc. | ANDA 40-258 | 2/26/99 | 3/2/99 | ||
| Leucovorin Calcium Tablets, 15 mg (base)/vial | Invamed Inc. | ANDA 75-327 | 3/24/99 | 3/29/99 | ||
|
Leukeran (chlorambucil) Tablets, Rx |
GlaxoSmithKline | NDA 10-669/S28 | 11/13/03 | 11/25/03 | 12/2/03 | |
|
Leukeran (chlorambucil) 2 mg Tablets, Rx
|
Glaxo Wellcome, Inc | NDA 10-669/S-021, S-022, S-023 | 7/24/01 | 7/23/02 | ||
|
Leukeran (chlorambucil) Tablets, Rx
|
Glaxo Wellcome, Inc | NDA 10-669/S-024 | 06/20/01 | 07/31/02 | ||
| Leuprolide Acetate Injection, 1 mg/0.2 mL, Rx | Gensia Sicor Pharmaceuticals, Inc. | ANDA 75-471 | 10/25/00 | 11/6/00 | ||
| Leuprolide Acetate Injection, 1 mg/0.2 mL, Rx | Genzyme Corporation | ANDA 75-721 | 11/29/01 | 4/14/03 | ||
| Leuprolide Acetate Injection, 1 mg/0.2 mL, Rx | Bedford Laboratories | ANDA 74-728 | 8/4/98 | 8/5/98 | 3/15/99 | |
| Leustatin (cladribine), | Ortho Biotech Products, L.P. | NDA 20-229/S-021 | 8/22/02 | 8/30/02 | ||
| Leustatin (cladribine) Injection, | Ortho Biotech Products, L.P. | NDA 20-229/S-4, S-7 | 8/20/02 | 8/26/02 | ||
| Levaquin, Rx | RW Johnson | NDA 20-634, S004 & 20-635, S003 | 12/17/98 | 7/2/99 | ||
| Levaquin Indications: uncomplicated urinary tract infection (UTI) | ||||||
| Levaquin (levofloxacin) Tablets & Injection, Rx | R.W. Johnson Pharmaceutical | NDA 20-634/S29 & 20-635/S29 | 3/5/04 | 3/10/04 | 4/7/04 | |
| Levaquin (levofloxacin) Tablets & Injection, Rx | Johnson & Johnson Pharmaceutical | NDA 20-634/S28 & 20-635/S27 | 10/23/03 | 12/4/03 | ||
| Levaquin (levofloxacin) Tablets & Injection, Rx | R.W. Johnson Pharmaceutical Research Institute |
NDA 20-634/S25 & 20-635/S22 | 10/30/02 | 1/29/03 | ||
| Levaquin (levofloxacin) Tablets & Injection, Rx | R.W. Johnson Pharmaceutical Research Institute |
NDA 20-634/S15, S21 & S22 & 20-635/S12, S19 & S20 | 12/18/01 | 2/12/01 | 2/12/01 | |
| Levaquin (levofloxacin) Tablets & Injection, 250mg, 500mg, & 750mg / IV - 25mg/mL; 20 & 30mL(new) vials 5mg/mL; 50, 100, & 150mL(new), Rx | R.W. Johnson Pharmaceutical Research Institute |
NDA 20-634/S-013 & 20-635/S-010 | 9/8/00 | 9/12/00 | 9/12/00 | |
| Levaquin Indication: Treatment of complicated skin and skin structure infections. | ||||||
| Levaquin Tablets,250mg and 500mg / Levaquin Injection,25mg/ml and 5mg/ml, Rx | R.W. Johnson Pharmaceutical Research Institute |
NDA 20-634/S-008 & 20-635/S-007 | 2/2/00 | 2/3/00 | ||
| Levaquin Indication: Treatment of levofloxacin-susceptible strains of penicillin-resistant Steptococcus pneumoniae in patients with community acquired pneumonia | ||||||
| LEVITRA (vardenafil HCl) Tablets, Rx | Bayer Corporation | NDA 21-400 | 8/19/03 | 8/28/03 | 8/20/03 | 10/29/03 |
| Levlite (levonorgestrel 0.100 mg and ethinyl estradiol Tablets, 0.020 mg) | Berlex Laboratories | NDA 20-860 | 7/14/98 | 7/14/98 | 1/21/99 | |
| Levo-T (levothyroxine sodium tablets, USP), Rx | Alara Pharmaceutical Corporation | NDA 21-342/S2 | 8/21/03 | 8/28/03 | 8/28/03 | |
| Levo-T (levothyroxine sodium) Tablets, USP, Rx | Alara Pharmaceutical Corporation | NDA 21-342/S1 | 12/8/03 | 12/11/03 | 12/11/03 | |
| Levo-T (levothyroxine sodium tablets, USP), 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg., Rx | Mova Pharmaceutical Corporation | NDA 21-342 | 3/1/02 | 6/19/02 | 5/24/02 | 6/19/02 |
| Levo-T Indications: Hypothyroidism and supression of thyroid-stimulating hormone. | ||||||
| Levobunolol Hydrochloride Ophthalmic Solution USP, 0.5%, Rx | Novex Pharma | ANDA 75-475 | 8/3/00 | 11/6/00 | ||
| Levobunolol Hydrochloride Ophthalmic Solution USP, 0.25%, Rx | Novex Pharma | ANDA 75-473 | 8/3/00 | 11/6/00 | ||
| Levocarnitine Injection USP, 200, mg/mL, Rx | Gensia Sicor Pharmaceuticals, Inc. | ANDA 75-881 | 3/29/01 | 3/30/01 | 12/14/01 | |
| Levocarnitine Injection USP, 200, mg/mL, Rx | Luitpold Pharmaceuticals, Inc. | ANDA 75-861 | 6/22/01 | 6/26/01 | ||
| Levocarnitine Injection USP, 200 mg/mL, Rx | Bedford Laboratories | ANDA 75-567 | 3/29/01 | 3/30/01 | 12/17/01 | |
| Levofloxacin Tablets, 250 mg, 500 mg and 750 mg, Rx (Tentatively Approved) | Teva Pharmaceuticals | ANDA 76-361 | 4/26/04 | |||
| Levofloxacin Tablets, 250 mg and 500 mg, Rx (Tentatively Approved 12/10/2003) | Mylan Pharmaceuticals | ANDA 76-276 | 12/10/03 | |||
| Levolet (levothyroxine sodium) Tablets, USP, Rx | Vintage Pharmaceuticals | NDA 21-137 | 6/6/03 | 6/9/03 | ||
| Levonorgestrel and Ethinyl Estradiol Tablets, Rx | Barr Laboratories, Inc. | ANDA 75-862 | 4/29/03 | |||
| Levonorgestrel Oral Tablets, 0.75mg, Rx | Women's Capital Corporation | NDA 21-045 | 7/28/99 | 8/4/99 Insert 8/4/99 |
||
| Levonorgestrel Indications: Emergency Contraception | ||||||
| Levorphanol Tartrate Tablets USP,2 mg, Rx | Roxane Laboratories Inc. | ANDA 74-278 | 3/31/00 | 4/4/00 | ||
| Levothyroxine Sodium Tablets USP, 0.025, 0.05, 0.075, 0.088, 0.1, 0.112, 0.125, 0.15, 0.175, 0.2 & 0.3 mg, Rx | Mylan Pharmaceuticals Inc. | ANDA 76-187 | 6/5/02 | 7/8/03 | 7/8/03 | |
| Levoxyl (levothyroxine sodium) Tablets, | Jones Pharma Inc. | NDA 21-301/S6 | 7/23/03 | 8/6/03 | ||
| Levoxyl (levothyroxine sodium) Tablets, | Jones Pharma Inc. | NDA 21-301/S2 | 7/17/02 | 7/24/02 | ||
| Levoxyl (levothyroxine sodium) Tablets, 25, 50, 88, 100, 125, 137, 150, 175 200 and 300 mcg strengths | Jones Pharma Inc. | NDA 21-301 | 5/25/01 | 6/14/01 | 6/14/01 | 1/7/02 |
| LEVULAN® KERASTICK, (aminolevulinic acid HCl) for Topical Solution, 20%, | DUSA Pharmaceuticals | NDA 20-965/S4 | 7/11/03 | 7/28/03 | ||
| LEVULAN® KERASTICK, (aminolevulinic acid HCl) for Topical Solution, 20%, | DUSA Pharmaceuticals | NDA 20-965/S3 | 6/27/03 | 7/3/03 | 7/8/03 | |
| Levulan (aminolevulinic acid HC1) Topical Solution, 20%, Rx | DUSA Pharmaceticals, Incorporated | NDA 20-965/S-002 | 3/26/03 | 4/1/03 | 4/1/03 | |
| LEVULAN® KERASTICK (aminolevulinic acid HCl) for Topical Solution, 20%, | Guidelines, Incorporated | NDA 20-965 | 12/7/99 | 12/28/99 | 12/28/99 | 4/10/02 |
| Lexapro (escitalopram oxalate) Tablets & Oral Solution, Rx | Forest Pharmaceuticals | NDA 21-323/S10 & 21-365/S5 | 4/8/04 | |||
| Lexapro (escitalopram oxalate) Tablets & Oral Solution, Rx | Forest Pharmaceuticals | NDA 21-323/S3/S7 & 21-365/S1/S4 | 12/18/03 | 12/22/03 | 12/22/03 | |
| Lexapro (escitalopram oxalate) Oral Solution, 5 mg/5 mL, Rx | Forest Pharmaceuticals | NDA 21-365 | 11/27/02 | 12/9/02 | 12/3/02 | |
| Lexapro (escitalopram oxalate) Tablets, 5 mg, 10 mg, and 20 mg, Rx | Forest Laboratories, Inc. | NDA 21-323/S1 & 21-440 | 8/29/02 | 8/30/02 | 4/12/04 | |
| Lexapro (escitalopram oxalate) Tablets, 5 mg, 10 mg, and 20 mg, Rx | Forest Laboratories, Inc. | NDA 21-323 | 8/14/02 | 8/21/02 | 8/19/02 | 4/12/04 |
| Lexiva (Fosamprenavir Calcium) Tablets, 700mg, Rx | GlaxoSmithKline | NDA 21-548 | 10/20/03 | 10/27/03 | 10/27/03 | |
| Lexxel (Enalapril Maleate/Felodipine ER) Tablets, | Astra Pharmaceuticals, L.P. | NDA 20-668/S-009 | 6/11/03 | 7/8/03 | ||
| Lexxel (Enalapril Maleate/Lelodipine ER) Tablets, | Astra Pharmaceuticals, L.P. | NDA 20-668/S-003 | 10/28/98 | 7/25/02 | 7/25/02 | 7/25/02 |
| Librium (chlordiazepoxide hydrochloride) Injection, | ICN Pharmaceuticals, Inc. | NDA 12-301/S-023 | 5/7/02 | 5/16/02 | ||
| Lidocaine and Prilocaine Cream, 2.5%, Rx | Altana, Inc. | ANDA 76-453 | 8/18/03 | |||
| Lidoderm Patch (lidocaine patch 5% w/w), Dermal Patch, Rx | Hind Health Care, Inc. | NDA 20-612 | 3/19/99 | 3/29/99 | 3/29/99 | 6/17/99 |
| Lidoderm Patch Indications: For the treatment of pain in post-herpetic neuralgia. | ||||||
| Lidocaine and Prilocaine Cream, Rx | Atrix Laboratories | ANDA 76-320 | 8/27/03 | |||
| Lidocaine and Prilocaine Cream, Rx | Hi-Tech Pharmacal | ANDA 76-290 | 9/25/03 | |||
| Lidocaine Hydrochloride in 5% Dextrose Injection, | Baxter Healthcare Corp | NDA 18-461/S52 | 12/11/03 | 12/16/03 | ||
| Lidocaine Hydrochloride in 5% Dextrose Injection in Viaflex Plastic, | Baxter Healthcare Corp | NDA 18-461/S50 | 1/23/02 | 2/5/02 | 9/10/02 | 9/10/02 |
| Lidocaine Hydrochloride Jelly USP, 2%, Rx | Akorn, Inc. | ANDA 40-333 | 2/12/03 | |||
| Lidocaine Hydrochloride USP, 1% and 2% (5 mL Single Dose Ansyr Plastic Syringe) Injection, Rx | Abbott Laboratories | ANDA 40-302 | 9/28/98 | 9/28/98 | ||
| Lioresal Intrathecal (Baclofen) Injection, | Medtronic | NDA 20-075/S20 | 5/8/03 | 7/9/03 | ||
| Lioresal (Baclofen) Injection, | Medtronic Drug Delivery | NDA 20-075/S17 | 11/20/02 | 12/6/02 | ||
| Lioresal (Baclofen) Injection, | Medtronic Drug Delivery | NDA 20-075/S14 & 16 | 3/6/02 | 3/12/02 | ||
| Limbitrol
(chlordiazepoxide and amitriptyline hydrochloride) Tablets,
Rx |
ICN Pharmaceuticals, Inc. | NDA 16-949/S-033 | 6/5/01 | 11/25/02 | ||
| Lipitor (atorvastatin calcium) tablets, Rx | Parke-Davis Pharmaceutical Research, agent for Warner-Lambert Export, Limited | NDA 20-702 /S-003/S-005 |
7/10/98 | 7/10/98 | 11/12/98 | |
| Lipitor Indications: S-003 provides for the use of Lipitor as an adjunctive therapy to diet for the treatment of patients with elevated serium triglyceride levels (Frederickson Type IV). S-005 provides for the use of Lipitor by patients with primary dysbetalipoproteinemia (Frederickson Type III) who do not respond adequately to diet. | ||||||
| Lipitor (atorvastatin calcium) tablets, Rx | Parke-Davis Pharmaceutical Research, agent for Warner-Lambert Export, Limited | NDA 20-702 /S-004 |
2/2/98 | 10/23/98 | ||
| Lipitor (atorvastatin calcium) tablets, Rx | Parke-Davis Pharmaceutical Research, agent for Warner-Lambert Export, Limited | NDA 20-702 /S-14 |
8/28/98 | 12/14/98 | ||
| Lipitor (atorvastatin calcium) tablets, Rx | Parke-Davis, agent for Warner-Lambert Export, Limited | NDA 20-702 /S-18 |
12/2/99 | 12/29/99 | 4/23/03 | |
| Lipitor (atorvastatin calcium) Tablets, Rx | Pfizer Ireland Pharmaceuticals | NDA 20-702 /S-25 |
6/15/01 | 11/6/01 | 11/6/01 | 4/10/02 |
| Lipitor (atorvastatin calcium) Tablets, Rx | Pfizer, Inc. | NDA 20-702/S-33 | 10/18/02 | 10/28/02 | 10/18/02 | |
| Lipitor (atorvastatin calcium) Tablets, Rx | Pfizer Ireland Pharmaceuticals | NDA 20-702 /S29 & S34 |
4/22/02 | 5/2/02 | 4/24/02 | |
| Lipitor (atorvastatin calcium) Tablets, Rx | Pfizer | NDA 20-702/S37 | 9/29/03 | 10/9/03 | 10/10/03 | |
| Lipitor (atorvastatin calcium) Tablets, Rx | Pfizer | NDA 20-702/S36 | 5/12/03 | 7/9/03 | 7/9/03 | |
| Liposyn II (I.V. Fat Emulsion), 20% and 10%, Rx | Abbott Laboratories | NDA 18-991/S-025 & 18-997/S-026 | 4/14/03 | |||
| Liposyn III 20% (I.V. Fat Emulsion), Rx | Abbott Laboratories | NDA 18-970/S13 | 4/3/03 | 4/18/03 | ||
| Liposyn III 10% (I.V. Fat Emulsion), Rx | Abbott Laboratories | NDA 18-969/S-012 | 3/24/03 | 3/26/03 | ||
| Liposyn III 30% (I.V. Fat Emulsion), Rx | Abbott Laboratories | NDA 20-181/S-001 | 3/12/03 | 4/1/03 | ||
| Lisinopril & Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg, 20 mg/12.5 mg & 20 mg/25 mg, Rx | West-ward Pharmaceutical Corp. | ANDA 76-265 | 7/8/02 | |||
| Lisinopril & Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg, 20 mg/12.5 mg & 20 mg/25 mg, Rx | Eon Labs, Inc. | ANDA 76-262 | 7/1/02 | |||
| Lisinopril & Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg, 20 mg/12.5 mg & 20 mg/25 mg, Rx | Purepac Pharmaceutical Co. | ANDA 76-230 | 7/1/02 | |||
| Lisinopril & Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg, 20 mg/12.5 mg & 20 mg/25 mg, Rx | Watson Laboratories, Inc. | ANDA 76-194 | 7/1/02 | |||
| Lisinopril Tablets USP, 2.5, 5 & 10mg, Rx | Purepac Pharmaceutical Co. | ANDA 76-180 | 7/1/02 | |||
| Lisinopril Tablets USP, 2.5, 5 & 10mg, Rx Tentatively Approved | Purepac Pharmaceutical Co. | ANDA 76-180 | 1/18/02 | 4/11/03 | ||
| Lisinopril Tablets USP, 20, 30, & 40 mg, Rx | Purepac Pharmaceutical Co. | ANDA 76-164 | 7/1/02 | |||
| Lisinopril Tablets USP, 20, 30, & 40 mg, Rx Tentatively Approved | Purepac Pharmaceutical Co. | ANDA 76-164 | 3/8/02 | 4/11/03 | ||
| Lisinopril & Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg, 20 mg/12.5 mg, 20 mg/25 mg, Rx | Mylan Pharmaceuticals, Inc. | ANDA 76-113 | 7/1/02 | |||
| Lisinopril & Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg, 20 mg/12.5 mg, 20 mg/25 mg, Rx Tentatively Approved | Mylan Pharmaceuticals, Inc. | ANDA 76-113 | 1/7/02 | 4/10/03 | ||
| Lisinopril Tablets USP, 2.5, 5, 10, 20, 30, & 40 mg, Rx | Torpharm | ANDA 76-102 | 9/30/02 | |||
| Lisinopril Tablets USP, 2.5, 5, 10, 20, 30, & 40 mg, Rx | Mylan Pharmaceuticals, Inc. | ANDA 76-071 | 7/1/02 | |||
| Lisinopril Tablets USP, 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg, & 40 mg, Rx 2nd Tentative Approval | Mylan Pharmaceuticals, Inc. | ANDA 76-071 | 2/8/02 | 4/10/03 | ||
| Lisinopril Tablets USP, 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg, & 40 mg, Rx Tentatively Approved | Mylan Pharmaceuticals, Inc. | ANDA 76-071 | 9/10/01 | 4/16/03 | ||
| Lisinopril Tablets USP, 30 mg, Rx | West-ward Pharmaceutical Corp. | ANDA 76-063/S2 & S3 | 6/27/03 | |||
| Lisinopril Tablets USP, 2.5, 5, 10, 20, 30 & 40 mg, Rx | West-ward Pharmaceutical Corp. | ANDA 76-063 | 7/1/02 | |||
| Lisinopril Tablets USP, 2.5, 5, 10, 20, 30 & 40 mg, Rx | Watson Laboratories, Inc. | ANDA 76-059 | 7/1/02 | |||
| Lisinopril Tablets USP, 2.5, 5, 10, 20, 30 & 40 mg, Rx Tentatively Approved | Watson Labs | ANDA 76-059 | 2/5/02 | 4/10/03 | ||
| Lisinopril & Hydrochorothiazide Tablets USP, 10 mg/12.5 mg, 20mg/12.5 mg & 20 mg/25 mg, Rx | Ranbaxy Pharmaceuticals Inc. | ANDA 76-007 | 7/1/02 | 4/10/03 | ||
| Lisinopril Tablets USP, 10 mg/12.5 mg, 20mg/12.5 mg & 20 mg/25 mg, Rx Tentatively Approved | Ranbaxy Laboratories Limited | ANDA 76-007 | 1/4/02 | |||
| Lisinopril Tablets USP, 2.5, 5, 10, 20, 30 & 40 mg, Rx | Lek Pharmaceutical and Chemical Company | ANDA 75-999 | 7/1/02 | |||
| Lisinopril Tablets USP, 2.5, 5, 10, 20, 30 & 40 mg, Rx Tentatively Approved | Lek Pharmaceutical and Chemical Company | ANDA 75-999 | 12/19/01 | 4/16/03 | ||