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|
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 |
|---|---|---|---|---|---|---|
| IBU (Ibuprofen) Tablets, 400, 600 & 800 mg, Rx | BASF Corporation | ANDA 75-682 | 11/14/01 | |||
| Ibuprofen Capsules, 200 mg | Banner Pharmacaps, Inc. | NDA 21-472/S1 | 1/22/02 | 2/2/04 | 2/2/04 | |
| Ibuprofen Capsules, 200 mg | Banner Pharmacaps, Inc. | NDA 21-472 | 10/18/02 | 10/28/02 | ||
| Ibuprofen Capsules, 200 mg, OTC | Pharmaceutical Formulations | ANDA 74-782 | 7/6/98 | 7/6/98 | 3/30/99 | |
| Ibuprofen Oral Suspension USP, 100 mg/5 mL, OTC | Alpharma | ANDA 74-916 | 1/9/98 | 3/15/99 | ||
| Ibuprofen Oral Suspension USP, 100 mg/5 mL. | L. Perrigo Company | ANDA 74-937 | 12/22/98 | 12/22/98 | 1/10/02 | 1/10/02 |
| Ibuprofen Oral Suspension USP, 100 mg/5 mL, Rx | Alpharma | ANDA 74-978 | 1/30/98 | 3/25/98 | 3/19/99 | |
| Ibuprofen Oral Suspension USP, 40 mg/mL. | L. Perrigo Company | ANDA 75-217 | 12/16/98 | 12/18/98 | 12/28/01 | 12/28/01 |
| Ibuprofen Tablets, 200 mg, OTC | Neil Laboratories | ANDA 76-460 | 11/26/03 | |||
| Ibuprofen and Pseudoephedrine Hydrochloride Oral Suspension, OTC | Perrigo Co. | ANDA 76-478 | 11/5/03 | |||
| Ibuprofen and Pseudoephedrine Hydrochloride Tablets USP, 200 mg & 30 mg, OTC | Pharmaceutical Formulations, Inc. | ANDA 75-588 | 4/8/02 | 12/24/03 | ||
| Ibuprofen and Pseudoephedrine Hydrochloride Tablets USP, 200 mg & 30 mg, OTC Tentatively Approved | Pharmaceutical Formulations, Inc. | ANDA 75-588 | 4/17/01 | 4/24/01 | ||
| Ibuprofen and Pseudoephedrine Hydrochloride Tablets USP, 200 mg/30 mg, OTC | Ohm Laboratories, Inc. | ANDA 74-567 | 4/17/01 | 4/24/01 | ||
| Ibuprofen Tablets (round and capsule shaped tablets) USP, 200mg | Novopharm N.C. Inc. | ANDA 74-931 | 7/20/98 | 7/20/98 | 8/6/03 | |
| Ibuprofen Tablets (round and capsule shaped tablets) USP, 200mg | LNK International | ANDA 75-139 | 3/1/99 | 3/4/99 | ||
| Ibuprofen Chewable Tablets, 50 & 100 mg, OTC | L. Perrigo Co. | ANDA 76-359 | 1/16/04 | 1/22/04 | ||
| Ibuprofen Tablets USP, 200 mg, OTC | Dr. Reddy's Laboratories Ltd. | ANDA 76-117 | 11/20/01 | |||
| Ibuprofen Tablets USP, 400, 600 & 800 mg, Rx | Dr. Reddy's Laboratories Ltd. | ANDA 76-112 | 10/31/01 | 1/17/02 | 1/17/02 | |
| Ibuprofen Tablets USP, 200mg, OTC | L. Perrigo Company | ANDA 75-995 | 3/14/02 | |||
| Ibuprofen Tablets USP, 200mg, OTC | BASF Corp. | ANDA 75-661 | 12/12/01 | 12/24/03 | ||
| Ibuprofen Tablets USP, 200mg | LNK International | ANDA 75-010 | 3/1/99 | 3/4/99 | ||
| Idamycin PFS (idarubicin hydrochloride) Injection USP, | Pharmacia & Upjohn | NDA 50-734/S5 | 5/1/03 | 7/9/03 | 7/9/03 | |
| Idamycin (idarubicin hydrochloride) Injection USP, | Pharmacia & Upjohn Company | NDA 50-661/S-008 | 10/11/02 | 10/21/02 | ||
| Idamycin (idarubicin hydrochloride) Injection USP, | Pharmacia & Upjohn Company | NDA 50-661/S-007 | 9/30/02 | 10/2/02 | ||
| Idarubicin Hydrochloride Injection, 5 mg/Vial, 10 mg/vial & 20 mg/vial (Single Dose Vials), Rx | Gensia Sicor Pharmaceuticals, Inc. | ANDA 65-037 | 5/1/02 | |||
| Idarubicin Hydrochloride Injection, 1 mg/mL Packaged in 5 mg/5 mL, 10 mg/10 mL, 20 mg/20 mL single dose vials, Rx | Gensia Sicor Pharmaceuticals, Inc. | ANDA 65-036 | 5/1/02 | |||
| IDkit:Hp Oridion BreathID Breath Test System, containing C-Urea (13C-urea tablet for oral solution) 75 mg, and Citrica (citric acid powder for oral solution) 4.0 g, | Oridion BreathID Inc. | NDA 21-314 | 12/17/02 | 1/29/03 | ||
| Ifosfamide Injection, Rx | Sicor Pharmaceuticals | ANDA 76-657 | 3/17/04 | |||
| Ifosfamide Injection, Rx | American Pharmaceutical Partners, Inc. | ANDA 76-078 | 5/28/02 | |||
| Ifosfamide Injection/Mesna Injection Kit, Rx | Gensia Sicor Pharmaceuticals, Inc. | ANDA 75-874 | 2/26/02 | |||
| Iletin I Insulin, Lente Iletin I Insulin, and NPH Iletin I Insulin, respectively. | Eli Lilly and Company | NDA 17-931/S-025, 17-933/S-026 & 17-936/S-027 | 2/11/02 | 3/5/02 | ||
| Imagent (Perflexane Lipid Microspheres), | IMCOR Pharmaceutical | NDA 21-191/S1 | 4/21/04 | |||
| Imagent, | Alliance Pharmaceuticals, Inc. | NDA 21-191 | 5/31/02 | 6/3/02 | 5/31/02 | 9/23/02 |
| IMDUR (isosorbide mononitrate) Extended Release Tablets, 30, 60 and 120 mg, Rx | Schering Corporation | NDA 20-225/S-008 | 1/22/03 | 1/27/03 | ||
| Imitrex (sumatriptan) Tablets, Spray, Injection, | GlaxoSmithKline | NDA 20-132/S14, 20-626/S7 & 20-080/S30 | 7/28/03 | 8/15/03 | ||
| Imitrex (sumatriptan succinate) Injection, | Glaxo Wellcome | NDA 20-080/S29 | 1/3/03 | 1/23/03 | ||
| Imitrex (sumatriptan succinate) Injection, | Glaxo Wellcome | NDA 20-626/S-006 | 5/10/02 | 5/21/02 | ||
| Imitrex (sumatriptan succinate) Tablets, | GlaxoSmithKline | NDA 20-132/S15 | 6/30/03 | |||
| Imodium Advanced (Loperamide HCI and Simethicone) Caplet, | McNeil Consumer Healthcare | NDA 21-140/S2 | 1/27/03 | 1/29/03 | 1/27/03 | |
| Imodium Advanced (Loperamide HCI and Simethicone) Caplet | McNeil Consumer Healthcare | NDA 21-140 | 11/29/00 | 12/12/01 | 12/12/01 | 12/12/01 |
| Imuran (azathioprine) Injection and Tablets, Rx | Prometheus Laboratories Inc. | NDA 16-324/S-026 & 17-391/S-011 | 12/19/02 | 1/29/03 | ||
| Indapamide Tablets USP, 1.25 mg and 2.5 mg, RX | Trigen Laboratories, Inc. | ANDA 75-201 | 12/4/98 | 12/4/98 | ||
| Indapamide Tablets, 1.25 mg and 2.5 mg, RX | Alphapharm Pty. | ANDA 75-105 | 7/23/98 | 7/23/98 | 1/4/02 | 1/4/02 |
| INDIUM In 111 Oxyquinoline Solution, | Amersham Health | NDA 19-044/S-018 | 9/19/02 | 9/24/02 | ||
| Indocin I.V. (Indomethacin), | Merck & Company | NDA 18-878/S18 & S19 | 5/6/03 | 7/9/03 | ||
| Indomethacin Capsules USP, 25 & 50 mg, Rx | Able Labs | ANDA 76-666 | 12/17/03 | |||
| Indomethacin Extended-release Capsules USP, 75 mg, Rx | Able Labs | ANDA 76-114 | 2/6/02 | |||
| Indomethacin Extended-release Capsules USP, 75 mg | Eon Labs Manufacturing | ANDA 74-464 | 5/28/98 | 5/29/98 | 3/15/99 | |
| Infant's Motrin (ibuprofen oral suspension) Concentrated Drops, 50 mg/1.25 mL | McNeil Consumer Healthcare | NDA 20-603/S-003 | 4/15/99 | 4/30/02 | ||
| Infant's Motrin (50 mg/1.25 mL ibuprofen oral suspension). | McNeil Consumer & Specialty Pharmaceuticals | NDA 20-603/S-005 | 1/16/02 | 2/7/02 | 2/7/02 | |
|
Infants' Advil (ibuprofen oral
suspension) Concentrated
Drops,50 mg/1.25 mL. |
Whitehall-Robins Healthcare | NDA 21-812/SE5-003 | 1/12/00 | 1/21/00 | 1/21/00 | |
| Infants' Advil Indications: For use in children 6 months - 23 months | ||||||
| Infasurf (calfactant) Intratracheal Suspension, Rx, | ONY, Inc. | NDA 20-521/S8 | 12/12/02 | 1/29/03 | ||
| Infasurf (calfactant) Intratracheal Suspension, Rx, | ONY | NDA 20-521 | 7/1/1998 | 7/2/98 | 7/2/98 | 4/11/02 |
| Infasurf Indication: for the prevention and treatment of Respiratory Distress Syndrome (RDS) in neonates. | ||||||
| INFeD (iron dextran injection, USP), 50 mg/mL | Schein Pharmaceuticals, Inc. | NDA 17-441/S-161 | 4/18/01 | 5/3/01 | ||
| Infuvite Adult (Multiple Vitamins for Infusion) IV, | Sabex 2002 Inc. | NDA 21-559 | 6/16/03 | 7/8/03 | 7/8/03 | |
| Infuvite Adult (Multiple Vitamins for Infusion) IV, | Sabex 2002 Inc. | NDA 21-163/S5 | 2/12/03 | 2/25/03 | ||
| Infuvite Pediatric (Multiple Vitamins for Infusion), | Sabex 2002 Inc. | NDA 21-646 | 1/29/04 | 1/3/04 | ||
| Infuvite Pediatric (Multiple Vitamins for Infusion), | Sabex 2002 Inc. | NDA 21-265/S5 | 2/12/03 | 2/25/03 | ||
| Infuvite Pediatric (Multiple Vitamins for Infusion) IV, | Sabex Inc. | NDA 21-265 | 2/21/01 | 6/19/02 | 6/19/02 | 6/19/02 |
| Infulvite Indications: Maintenance of multivitamins in infants and children up to 11 years of age receiving parenteral nutrition. | ||||||
| Innofem Tablets (Estradiol Tablets, USP), 0.5 mg, 1 mg, and 2 mg. | Novo Nordisk Pharmaceuticals, Inc. | ANDA 40-312 | 11/19/99 | 12/30/99 | 7/11/01 | |
| Innohep (tinzaparin sodium) Injection, Rx | Pharmion Corporation | NDA 20-484/S-003 | 2/4/03 | 2/12/03 | ||
| Innohep (tinzaparin sodium) Injection, Rx | Bristol-Myers Squibb Pharma Company | NDA 20-484/S-002 | 2/5/02 | 4/17/02 | ||
| Innohep (tinzaparin sodium) Injection, Rx | Dupont Pharmaceutical Company | NDA 20-484 | 7/14/00 | 7/24/00 | 7/24/00 | 4/9/02 |
| Innohep Indications: for the treatment of acute symptomatic deep vein thrombosis with or without pulmonary embolism when administered in conjunction with warfarin sodium. | ||||||
| InnoPran XL (propranolol hydrochloride) Extended Release Capsules, 80 and 120 mg, Rx | Reliant Pharmaceuticals, LLC | NDA 21-438 | 3/12/03 | 7/8/03 | ||
| INOmax (nitric oxide), 100 and 800 ppm, Rx | INO Therapeutics Inc. | NDA 20-845 | 12/23/99 | 1/3/00 | 1/3/00 | 5/31/01 |
| INOmax Indication: INOmax in conjunction with ventilatory support and other appropriate agents, is indicated for the treatment of term and near-term (>34 weeks) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension, where it improves oxygenation and reduces the need for extracorporeal membrane oxygenation. | ||||||
| Inspra (eplerenone) Tablets, 25, 50, & 100 mg, Rx | G.D. Searle LLC | NDA 21-437/S2 | 10/7/03 | 10/10/03 | 10/10/03 | |
| Inspra (eplerenone) Tablets, 25, 50, & 100 mg, Rx | G.D. Searle LLC | NDA 21-437 | 9/27/02 | 10/2/02 | 10/1/02 | 1/30/03 |
| Intal (cromolyn sodium) Inhaler, | Aventis Pharmaceuticals | NDA 18-887/S20 | 2/11/04 | 3/3/04 | 4/5/04 | |
| Intal (cromolyn sodium) Nebulizer, | Aventis Pharmaceuticals | NDA 18-596/S30 | 2/11/04 | 3/3/04 | 4/5/04 | |
| Integrilin (eptifibatide) Injection, Rx | Millennium Pharmaceuticals, Inc. | NDA 20-718/S17 | 6/16/03 | 7/18/03 | 7/18/03 | |
| Integrilin (eptifibatide) Injection, 20 mg/10 ml and 75 mg/ 100 ml, Injection, Rx | COR Therapeutics | NDA 20-718 | 5/18 | 5/28/98 | 5/28/98 | 1/2/02 |
| Integrilin Indications: 1. For the treatment of patients with acute coronary syndrome (UA/NQMI), including patients who are to be managed medically and those undergoing percutaneous coronary intervention (PCI). In this setting, INTEGRILIN has been shown to decrease the rate of a combined endpoint of death or new myocardial infarction. 2. For the treatment of patients undergoing PCI. In this setting, INTEGRILIN has been shown to decrease the rate of a combined endpont of death, new myocardial infarction, or need for urgent intervention. | ||||||
| Integrilin (eptifibatide) Injection, Rx | COR Therapeutics, Inc. | NDA 20-718/S-002 | 9/20/99 | 9/24/99 | 9/24/99 | 7/5/01 |
|
Integrilin Indication:For the treatment of patients with acute coronary syndrome
(UA/NQMI), including patients who are to be managed medically and those undergoing percutaneous coronary intervention (PCI). In this setting, Integrilin has been shown to decrease the rate of a combined endpoint of death or new myocardial infarction. For the treatment of patients undergoing PCI. In this setting, Integrilin has been shown to decrease the rate of a combined endpoint of death, new myocardial infarction, or need for urgent intervention. |
||||||
| Integrilin (eptifibatide) Injection, Rx | COR Therapeutics, Inc. | NDA 20-718/S-010 & S-13 | 6/8/01 | 11/6/01 | 11/6/01 | 1/14/02 |
| Interferon alfa-2a | Hoffman-LaRoche | BLA 103145/5026 | 9/10/03 | 10/29/03 | ||
| Intralipid I.V. Fat Emulsion, 10, 20 & 30% | Fresenius Kabi | NDA 17-643/S70, 18-449/S37 & 19-942/S10 | 4/16/04 | |||
| Intron (interferon alfa 2b) (REBETRON COMBINATION THERAPY), | Schering Corporation | NDA 20-903/S-025 | 11/13/02 | 11/14/02 | ||
| Intron (interferon alfa 2b) (REBETRON COMBINATION THERAPY), | Schering Corporation | NDA 20-903/S-024 | 11/13/02 | |||
| Intron (interferon alfa 2b) (REBETRON COMBINATION THERAPY), | Schering Corporation | NDA 20-903/S-023 | 9/3/02 | 9/11/02 | ||
| Invanz (Ertapenem Sodium) | Merck & Co. | NDA 21-337 | 11/9/01 | 1/28/02 | 1/28/02 | 1/29/02 |
| Inversine (mecamylamine hydrochloride) Tablets, 2.5 mg, | Targacept, Inc. | NDA 10-251 / S-024 | 10/18/02 | 10/28/02 | ||
| INVIRASE (saquinavir mesylate) Capsules, 200 mg, Rx | Hoffman-La Roche, Inc | NDA 20-628/S20 | 12/24/03 | 1/14/04 | 1/15/04 | |
| INVIRASE (saquinavir mesylate) Capsules, | Hoffman-La Roche, Inc | NDA 20-628/S-016 | 6/24/02 | 7/2/02 | 6/25/02 | |
| Ionamin (Phentermine resin) Capsules, | Celltech Pharmaceuticals | NDA 11-613/S-026 | 10/8/03 | 10/16/03 | ||
| Iopamidol-250/-300/-370 (Iopamidol Injection USP, 51 %, 61%, 76%) | Abbott Laboratories | ANDA 75-005 | 2/24/98 | 3/19/99 | ||
| Iopamidol-250/-300/-370 (Iopamidol Injection USP, 51 %, 61%, 76%),Rx | Cook Imaging Corporation | ANDA 74-881 | 7/28/00 | 10/31/00 | ||
| Iopidine (apraclonidine ophthalmic solution), 5%, | Alcon Laboratories, Inc. | NDA 20-258/S-019 | 5/9/03 | 7/9/03 | 7/9/03 | |
| Iopidine (apraclonidine ophthalmic solution), 1%, | Alcon Laboratories, Inc. | NDA 19-779/S-015 | 5/15/03 | |||
| Iopidine (apraclonidine ophthalmic solution), 1%, | Alcon Laboratories, Inc. | NDA 19-779/S-014 | 3/22/02 | 3/29/02 | 3/22/02 | |
| Ipratropium Bromide Inhalation Solution, 0.02%, Rx | Roxane Laboratories, Inc. | ANDA 75-867 | 7/22/02 | |||
| Ipratropium Bromide Inhalation Solution, 0.02%, Rx | Bausch & Lomb Pharmaceuticals, Inc. | ANDA 75-835 | 10/15/01 | |||
| Ipratropium Bromide Inhalation Solution, 0.02%, Rx | Aslung Pharmaceutical, L.P. | ANDA 75-693 | 1/26/01 | 3/5/01 | ||
| Ipratropium Bromide Inhalation Solution, 0.02%, Rx | Nephron Pharmaceuticals Corporation | ANDA 75-562 | 9/27/01 | |||
| Ipratropium Bromide Inhalation Solution, 0.02%, Rx | Warrick Pharmaceuticals | ANDA 75-507 | 1/19/01 | 3/5/01 | ||
| Ipratropium Bromide Inhalation Solution, 0.02% (packaged in 2.5 mL plastic ampules), Rx | Novex Pharma | ANDA 75-441 | 3/28/01 | 3/30/01 | 6/11/02 | |
| Ipratropium Bromide Inhalation Solution, 0.02% (packaged in 0.5 mg/2.5 mL unit-dose vials) Rx | Steripak Limited | ANDA 75-313 | 2/7/00 | 8/6/03 | ||
| Ipratropium Bromide Inhalation Solution, 0.02%, Rx | Alpharma | ANDA 75-111 | 4/23/99 | 4/28/99 | 1/4/02 | 1/4/02 |
| Ipratropium Bromide Nasal Solution, 0.03%, Rx | Novex Pharma | ANDA 76-156 | 4/18/03 | |||
| Ipratropium Bromide Nasal Solution, 0.06%, Rx | Novex Pharma | ANDA 76-155 | 4/18/03 | |||
| Ipratropium Bromide Nasal Spray, Rx | Roxane Laboratories | ANDA 76-664 | 11/5/03 | |||
| Ipratropium Bromide Nasal Spray, Rx | Roxane Laboratories | ANDA 76-598 | 11/5/03 | |||
| Iprivask (Desirudin) Injection, Rx | Aventis Pharmaceuticals, Inc. | NDA 21-271 | 4/4/03 | 4/18/03 | ||
| Iquix (Levofloxacin) Opthalmic Solution, 1.5%, Rx | Santen Incorporated | NDA 21-571 | 3/1/04 | 3/3/04 | 4/5/04 | |
| Iressa (Gefitinib) Tablets, Rx | AstraZeneca | NDA 21-399 | 5/5/03 | 5/12/03 | 5/5/03 | 7/15/03 |
| Irrigating Solution G (PL 325), | Baxter Healthcare Corporation | NDA 18-519/S-014 | 7/17/02 | 7/24/02 | ||
| Isoflurane, USP(Liquid for Inhalation), 100 mL and 250 mL. | Halocarbon Products Corporation | ANDA 75-225 | 10/20/99 | 12/30/99 | ||
| Isoptin SR (verapamil hydrochloride) Tablets, 120 mg, 180mg, and 240mg, Rx | Abbott Laboratories | NDA 19-152 /S-030 | 11/26/02 | 12/6/02 | ||
| Isordil Sublingual (isosorbide dinitrate) Tablets 2.5, 5 and 10 mg, Rx | Wyeth-Ayerst | NDA 12-940/S-044 | 9/16/01 | 11/21/02 | ||
| Isordil Titradose (isosorbide dinitrate) Tablets, 5, 10, 20, 30, & 40 mg, Rx | Wyeth-Ayerst | NDA 12-093/S-044 | 9/26/01 | 11/8/02 | ||
| Isosorbide Dinitrate Extended-release Tablets, 40 mg, Rx | Inwood Laboratories, Inc. | ANDA 40-009 | 12/30/98 | 1/24/02 | ||
| Isosorbide Mononitrate Extended-release Tablets, 60 mg, Rx | Zenith Goldline Pharmaceuticals, Inc. | ANDA 75-448 | 6/19/00 | 10/30/00 | ||
| Isosorbide Mononitrate Extended-release Tablets, 30 mg, 60 mg, & 120 mg, Rx | KV Pharmaceutical | ANDA 75-395 | 3/16/00 | 3/21/00 | ||
| Isosorbide Mononitrate Tablets, 10 mg and 20 mg, Rx | Purepac Pharmaceutical Company | ANDA 75-037 | 10/30/98 | 11/2/98 | ||
| Isosorbide Mononitrate Tablets, 20 mg, Rx | Westward Pharmaceutical Corp. | ANDA 75-361 | 10/5/00 | 10/30/00 | ||
| Isosorbide Mononitrate Extended-release tablets, 60 mg, Rx | Elan Pharmaceutical Research | ANDA 75-041 | 9/22/98 | 9/23/98 | 8/24/01 | 8/24/01 |
| Isosorbide Mononitrate Extended-release Tablets, 30 mg and 60 mg, Rx | Purepac Pharmaceutical Inc. | ANDA 75-306 | 12/31/98 | |||
| Isosorbide Mononitrate Tablets, 20 mg, Rx | Teva Pharmaceuticals USA | ANDA 75-147 | 11/27/98 | 1/2/02 | 1/2/02 | 1/2/02 |
| Isosorbide Mononitrate Extended-release Tablets, 60 mg, Rx | Brightstone Pharma | ANDA 75-166 | 10/7/99 | 12/30/99 | ||
| Isosorbide Mononitrate Extended-release Tablets, 60 mg, Rx | Kremers Urban | ANDA 75-155 | 10/30/98 | 11/3/98 | ||
| Isosorbride Mononitrate Extended-release Tablets, 60 mg, Rx | Dexcel Ltd. | ANDA 75-522 | 4/17/00 | 4/24/00 | 12/6/01 | |
| Isovue-M (iopamidol injection), | Bracca Diagnostics Inc. | NDA 18-735/SLR-043 | 7/8/02 | 7/9/02 | ||
| Isovue Multipack, | Bracca Diagnostics Inc. | NDA 20-237/S4 | 12/5/03 | 12/11/03 | ||
| Isovue (iopamidol injection) and Isovue Multipack (iopamidol injection-pharmacy bulk pack), | Bracca Diagnostics Inc. | NDA 18-735/SLR-044 & 20-237/SLR-002 | 6/20/02 | 6/24/02 | ||
| Isuprel (isoproterenol hydrochloride) Injection | Abbott Laboratories | NDA 10-515/S-022 | 5/5/99 | 5/6/99 | 5/6/99 | 6/20/01 |
| Itraconazole Capsules, 100 mg, Rx Tentatively Approved | Eon Labs Manufacturing, Inc. | ANDA 76-104 | 5/8/02 | |||
| Jadelle (Levonorgestrel) Implants, Rx | Population Council | NDA 20-544/S3 | 11/22/02 | 12/9/02 | 11/22/02 | |
| Jantoven (Warfarin Sodium) Tablets, Rx | Upsher-Smith | ANDA 40416 | 10/2/03 | |||
| Junelä 1.5/30 (Norethindrone Acetate and Ethinyl Estradiol) Tablets USP, 1.5 mg/0.03 mg, respectively), Rx | Barr Laboratories, Inc. | ANDA 76-381 | 5/30/03 | |||
| Junelä Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol) Tablets USP & Ferrous Fumarate Tablets, 1 mg/20 mcg, respectively), Rx | Barr Laboratories, Inc. | ANDA 76-081 | 9/18/03 | |||
| Junelä Fe 1.5/30 (Norethindrone Acetate and Ethinyl Estradiol) Tablets USP & Ferrous Fumarate Tablets, 1.5 mg/30 mcg, respectively), Rx | Barr Laboratories, Inc. | ANDA 76-064 | 9/18/03 | |||
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