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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 |
|---|---|---|---|---|---|---|
| R-Gene 10(Arginine Hydrocloride) Injection, 10% | Pharmacia & Upjohn | NDA 16-931/S-028 | 8/13/03 | 8/15/03 | 8/15/03 | |
| Radiogardase (Insoluble Prussian Blue) Capsules, 500mg, Rx | HEYL Chemisch-pharmazeutische Fabrik GmbH | NDA 21-626 | 10/2/03 | 10/10/03 |
10/2/03
|
12/30/03 |
| Ranitidine Capsules, 150 mg. & 300 mg., Rx | Cheminor Drugs Limited | ANDA 75-742 | 11/29/00 | 3/5/01 | ||
| Ranitidine Capsules, 150 mg. & 300 mg., Rx | TEVA Pharmaceuticals | ANDA 75-557 | 10/31/03 | |||
| Ranitidine Capsules, 150 mg. & 300 mg., Rx Approvable | TEVA Pharmaceuticals USA | ANDA 75-557 | 9/30/02 | |||
| Ranitidine Tablets, 75 mg., OTC | L. Perrigo Co. | ANDA 76-195 | 8/30/02 | |||
| Ranitidine Tablets USP,150 mg. & 30 mg., Rx | Genpharm Inc. | ANDA 75-564 | 10/27/00 | 11/6/00 | ||
| Ranitidine Tablets USP, 75 mg., OTC | Geneva Pharmaceuticals, Inc. | ANDA 75-519 | 9/26/02 | |||
| Ranitidine Tablets USP, 75 mg, OTC | Genpharm Inc. | ANDA 75-497 | 1/14/00 | 2/4/00 | ||
| Ranitidine Tablets USP, 150 mg and 300 mg, Rx | Ranbaxy Laboratories, Ltd. | ANDA 75-439 | 4/19/00 | 4/24/00 | ||
| Ranitidine Tablets USP 75 mg Tablets, OTC | Zenith Goldline Pharmaceuticals | ANDA 75-296 | 1/14/00 | 2/4/00 | ||
|
Ranitidine Tablets USP, 75 mg.,
Tablets, OTC Tentatively approved 1/29/1999 |
Cheminor Drugs Ltd.-Pharma Division | ANDA 75-294 | 1/29/99 | 1/29/99 | ||
| Ranitidine Tablets USP, 75 mg., Tablets, OTC | Cheminor Drugs Ltd.-Pharma Division | ANDA 75-294 | 3/28/00 | 3/31/00 | ||
| Rantidine Tablets USP,75 mg, OTC | Ranbaxy |
ANDA 75-254 | 1/14/00 | 2/4/00 | ||
|
Ranitidine Tablets USP, 75 mg,
OTC Tentatively approved: 10/5/1998 |
Chelsea Laboratories | ANDA 75-212 | 10/5/98 | 10/5/98 | ||
|
Ranitidine Tablets USP, 75 mg,
OTC Tentatively approved: 11/29/1999 |
Chelsea Laboratories | ANDA 75-212 | 11/29/99 | 12/29/99 | ||
| Ranitidine Tablets USP 75 mg Tablets, OTC | Chelsea Laboratories, Inc. | ANDA 75-212 | 1/14/00 | 1/24/00 | ||
| Ranitidine Tablets USP, 150 mg and 300 mg, Rx | Wockhardt Americas, Inc. | ANDA 75-208 | 12/17/98 | 12/22/98 | ||
| Ranitidine Tablets USP, 150 mg and 300 mg, Rx | Par Pharmaceutical, Inc. | ANDA 75-180 | 1/28/99 | 1/28/99 | ||
|
Ranitidine Tablets USP,75 mg,
OTC Tentatively Approved: 9/29/1998 |
Torpharm | ANDA 75-167 | 9/29/98 | 9/29/98 | ||
| Ranitidine Tablets USP,75 mg., Tentatively Approved: 4/8/1999 | Apotex Corp. | ANDA 75-167 | 4/8/99 | 4/16/99 | ||
| Ranitidine Tablets USP, 75 mg, OTC | Torpharm, Inc. | ANDA 75-167 | 5/4/00 | 5/22/00 | ||
| Ranitidine Tablets USP, 150 mg and 300 mg, Rx | Zenith Pharmaceuticals | ANDA 75-165 | 9/30/98 | 9/30/98 | ||
|
Rantidine Tablets USP,75 mg Tentatively Approved: 8/24/1998 |
Ranbaxy |
ANDA 75-132 | 8/24/98 | 1/12/99 | ||
| Rantidine Tablets USP,75 mg, OTC | Ranbaxy |
ANDA 75-132 | 1/14/00 | 1/24/00 | ||
|
Ranitidine Tablets USP,75 mg, Tentatively Approved: 1/26/1999 |
Novopharm N.C. Inc. | ANDA 75-094 | 1/26/99 | 1/26/99 | ||
| Ranitidine Tablets USP, 150 mg (base) & 300 mg (base). | Ranbaxy Pharmaceuticals, Inc. | ANDA 75-000 | 1/30/98 | 3/19/99 | ||
| Ranitidine Tablets USP, 150 mg (base) and 300 mg (base), Rx | Mylan Pharmaceuticals | ANDA 74-552 | 7/30/98 | 8/5/98 | ||
| Rapamune (sirolimus) Oral Solution & Tablets, 1 mg/mL & 1 and 2 mg respectively, Rx | Wyeth Pharmaceuticals | NDA 21-083/S-006 & 21-110/S-004 | 4/11/03 | 4/18/03 | 4/11/03 | |
| Rapamune (sirolimus) Oral Solution & Tablets, Rx | Wyeth Pharmaceuticals | NDA 21-083/S-015 & 21-110/S-015 | 10/2/03 | 10/10/03 | 10/10/03 | |
| Rapamune (sirolimus) Oral Solution & Tablets, 1 mg/mL & 1 and 2 mg respectively, Rx | Wyeth Pharmaceuticals | NDA 21-083/S-014 & 21-110/S-013 | 3/19/03 | 4/1/03 | 3/26/03 | |
| Rapamune (sirolimus) Oral Solution & Tablets, 1 mg/mL & 1 mg respectively, Rx | Wyeth Pharmaceuticals | NDA 21-083/S-012 & 21-110/S-011 | 1/31/03 | 2/12/03 | 2/13/03 | |
| Rapamune (sirolimus) Oral Solution & Tablets, 1 mg/mL & 1 mg respectively, Rx | Wyeth Pharmaceuticals | NDA 21-083/S-005; S-007; S-008; S-009; S-010 & 21-110/S-001; S-005; S-007; S-009; S-010 | 1/23/03 | 1/27/03 | 1/23/03 | |
| Rapamune (sirolimus) Tablets, Rx | Wyeth Pharmaceuticals | NDA 21-110/S18 | 2/23/04 | 3/3/04 | 4/5/04 | |
| Rapamune (sirolimus) Tablets, Rx | Wyeth Pharmaceuticals | NDA 21-110/S3 | 8/22/02 | 8/26/02 | ||
| Rapamune (sirolimus) Tablets, 1 mg/ml, Rx | Wyeth-Ayerst | NDA 21-110 | 8/25/00 | 9/6/00 | 10/11/01 | |
| Rapamune (sirolimus) Oral Solution, 1 mg/ml, Rx | Wyeth-Ayerst | NDA 21-083 | 9/15/99 | 1/21/00 | ||
| Rapamune Indication: Prophylaxis of organ rejection in patients receiving renal transplants. | ||||||
| Raplon (rapacuronium bromide) Injection,100 mg/5 mL, 200 mg/10 mL Vial. | Organon, Inc | NDA 20-984 | 8/18/99 | 9/24/99 | 9/24/99 | 7/2/01 |
| Raplon Indications: Indicated for outpatients and inpatients as an adjunct to general anesthesia to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgical procedures. | ||||||
| RAPTIVA EFALIZUMAB | Genentech | BLA 125075 | 10/27/03 | 11/18/03 | ||
| Rebetol (ribavirin) Capsules, | Schering Corporation | NDA 20-903/S32 | 10/10/03 | 10/16/03 | 10/16/03 | |
| Rebetol (ribavirin) Capsules, | Schering Corporation | NDA 20-903/S028 | 6/9/03 | 7/8/03 | 7/8/03 | |
| Rebetol (ribavirin) Capsules, | Schering Corporation | NDA 20-903/S025 | 11/13/02 | 7/31/03 | ||
| Rebetol (ribavirin) Capsules, | Schering Corporation | NDA 20-903/S023 | 9/3/02 | 9/5/02 | ||
| Rebetol (ribavirin) Capsules, | Schering Corporation | NDA 20-903/S020 | 3/6/02 | 3/12/02 | ||
| Rebetol (ribavirin) Capsules | Schering Corporation | NDA 20-903/S013 | 12/28/01 | 2/12/01 | ||
| Rebetol (ribavirin) Oral Solution, | Schering Corporation | NDA 21-546 | 7/29/03 | 8/6/03 | 8/6/03 | |
| Rebetol Rebetron Combination Therapy, | Schering Corporation | NDA 20-903/S030 | 7/9/03 | 7/10/03 | 7/9/03 | |
| Rebetol (ribavirin)/Intron A (interferon alfa-2b) (Rebetron Combination Therapy | Schering Corporation | NDA 20-903/S015 | 2/21/02 | 2/21/02 | ||
| Rebetol (ribavirin)/Intron A (interferon alfa-2b) (Rebetron Combination Therapy | Schering Corporation | NDA 20-903/S008, S011, S012 & S016 | 7/25/01 | 7/26/01 | 7/26/01 | |
| Rebetol (ribavirin)/Intron A (interferon alfa-2b, recombinant) | Schering Corporation | NDA 20-903 | 6/3/98 | 6/3/98 | 6/3/98 | 9/7/01 |
| Rebetol Indication:Treatment of chronic hepatitis C in patients with compensated liver disease who have relapsed following alpha interferon therapy. | ||||||
| Rebetron Combination Therapy, Rx | Schering-Plough | NDA 20-903/ S-025 | 11/13/02 | 11/18/02 | ||
|
Rebetron Combination Therapy (Rx only)consisting of Rebetol (ribavirin)200mg capsules and Intron A (interferon Alfa-2b, recombinant)3 million IU injectable |
Schering-Plough | NDA 20-903/ S-001/S-002 | 12/9/98 | 12/14/98 | 12/9/98 | |
| Rebetron Combination Therapy [SCH 30500 - Intron A (Interferon alfa-2b, recombinant) for Injection/ SCH 18908 - Ribavirin]., Rx | Schering-Plough | NDA 20-903/S-006 & S-007 | 3/13/01 | 4/25/01 | ||
| Refludan (lepirudin) Injection, 50mg/vial, Rx | Aventis Pharms | NDA 20-807 | 3/6/98 | 4/10/02 | 4/10/02 | |
| Reglan
(metoclopramide) Injection, Rx |
Baxter Healthcare
|
NDA 17-862/S50 & S51 | 4/19/04 | |||
| Reglan
(metoclopramide) Tablets, Injection,
and Syrup, Rx |
A.H.
Robins c/o: Wyeth-Ayerst Research
|
NDA
17-854/S-041, & 17-862/S-048, & 18-821/S-020 |
11/7/01 | 11/25/02 | ||
| Reglan (metoclopramide) Tablets, Rx | Schwartz Pharma, Inc. | NDA 17-854/S-040 | 4/22/03 | |||
| Reglan (metoclopramide) Tablets, Injection, & Syrup, Rx | Wyeth-Ayerst Laboratories | NDA 17-854/S039, 17-862/S042, & 18-821/S018 | 3/9/99 | 6/18/01 | ||
| Regonol (Pyridostigmine Bromide) Injection, | Sabex 2002, Inc. | NDA 17-398/S14 | 10/17/03 | 10/22/03 | ||
| Regular 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 | ||
| Relenza (zanamivir for inhalation), Rx | GlaxoSmithKline | 21-036/S006 | 8/6/03 | 8/15/03 | 8/15/03 | |
| Relenza (zanamivir for inhalation), Rx | GlaxoSmithKline | 21-036/S005 | 8/5/03 | 8/15/03 | 8/6/03 | |
| Relenza (zanamivir for inhalation), 5 mg, Rx | Glaxo Wellcome, Inc. | 21-036/S004 | 4/27/01 | 05/08/03 | ||
|
Relenza (zanamivir for inhalation),5 mg, Rx Patient Label |
Glaxo Wellcome, Inc. | 21-036/S001 | 4/26/00 | 4/27/00 | 4/27/00 | 4/12/04 |
| Relenza (zanamivir for inhalation) | GlaxoWellcome | NDA 21-036 | 7/26/99 | 12/30/99 | 7/27/99 | 12/27/99 |
| Relenza Indication: For the treatment of uncomplicated acute illness due to influenza virus in adults and adolescents twelve years and older who have been symptomatic for no more than two days. | ||||||
| Relpax (eletriptan) Tablets, 20 mg, 40 mg, and 80 mg, Rx | Pfizer Inc. | NDA 21-016 | 12/26/02 | 1/29/03 | 4/7/03 | 10/15/03 |
| Remeron (mirtazapine) Tablets, 15, 30 & 45 mg, Rx | Organon Inc. | NDA 20-415/S15 | 9/30/02 | 10/2/02 | ||
| Remeron (mirtazapine) Tablets, 15, 30 & 45 mg, Rx | Organon Inc. | NDA 20-415/S9 | 4/9/02 | 4/16/02 | 4/9/02 | |
| Remeron Soltab (mirtazapine) Orally Disintegrating Tablets, 15 mg, 30 mg, and 45 mg, Rx | Organon Inc. | NDA 21-208/S6 | 11/14/02 | 7/24/03 | ||
| Remeron Soltab (mirtazapine) Orally Disintegrating Tablets, 15 mg, 30 mg, and 45 mg, Rx | Organon | NDA 21-208 | 1/12/01 | 4/29/02 | 4/29/02 | 4/29/02 |
| Remeron Indications: Depression. | ||||||
| Remicade Infliximab |
Centocor, Inc. | BLA 103772 / 5056 | 9/3/03 | 11/3/03 | ||
| Remicade Infliximab |
Centocor, Inc. | BLA 103772 / 5020 | 9/3/03 | 11/3/03 | ||
| Reminyl (galantamine hydrobromide) Tablets & Oral Suspension, | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | NDA 21-169/S-007 & 21-224/S-005 | 1/30/03 | 9/9/03 | ||
| Reminyl (galantamine hydrobromide) Tablets & Oral Suspension, | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | NDA 21-169/S-003 & 21-224/S-003 | 4/19/02 | 5/2/02 | ||
| Reminyl (galantamine hydrobromide) Oral Solution, Rx | Janssen Research Foundation | NDA 21-224 | 6/22/01 | 11/6/01 | 11/6/01 | 3/5/02 |
| Reminyl (galantamine hydrobromide) Tablets, Rx | Janssen Research Foundation | NDA 21-169 | 2/28/01 | 4/9/01 | 8/16/01 | 12/18/01 |
| Reminyl Indications: The treatment of mild to moderate dementia of the Alzheimer's type. | ||||||
| Remodulin (treprostinil sodium) Injection, 1.0, 2.5, 5.0, and 10.0 mg/ml | United Therapeutics Corporation | NDA 21-272 | 5/21/02 | 5/23/02 | 5/23/02 | 7/31/02 |
| Renagel Tablets, 400mg & 800mg, Rx | GelTex Pharmaceuticals | NDA 21-179 | 7/12/00 | 7/14/00 | 7/14/00 | 3/11/04 |
| GelTex Indication: provides for a new dosage form of Renegel. | ||||||
| Renagel (sevelamer hydrochloride) Capsules & Tablets, Rx | Genzyme Corporation | NDA 20-926/S6 & 21-179/S2 | 2/6/04 | 3/3/04 | ||
| Renagel (sevelamer hydrochloride) Capsules, Rx | GelTex Pharmaceuticals | NDA 20-926 | 10/30/98 | 11/2/98 | 11/2/98 | 7/4/99 |
| GelTex Indication: for the reduction of serum phosphorus in patients with end stage renal disease who are on hemodialysis. | ||||||
| Renagel (sevelamer hydrochloride) Capsules, Rx | GelTex Pharmaceuticals | NDA 20-926/S002 | 5/5/00 | 2/22/00 | ||
| GelTex Indication: for the reduction of serum phosphorus in patients with end stage renal disease. | ||||||
| RenAmin (amino acid) Injection, Rx | Baxter Healthcare Corporation | NDA 17-493/S-068 | 4/30/03 | |||
| RenAmin (amino acid) Injection, Rx | Baxter Healthcare Corporation | NDA 17-493/S-067 | 1/17/03 | 1/27/03 | ||
| RenAmin (amino acid) Injection, Rx | Baxter Healthcare Corporation | NDA 17-493/S-065 | 1/3/03 | 1/23/03 | ||
| Renografin-60 - (Diatrizoate Meglumine and Diatrizoate Sodium Injection USP), Rx | Bracco Diagnostics Inc. | NDA 10-040/SLR-168 | 10/23/02 | 10/28/02 | ||
| Renova (tretionin) Cream, 0.02%, Rx | Johnson and Johnson Consumer Industries, Inc. | NDA 21-108/S1 | 7/14/02 | 7/15/02 | 7/15/02 | |
| Renova (tretionin) Cream, 0.02%, Rx | Johnson and Johnson Consumer Industries, Inc. | NDA 21-108 | 8/31/00 | 9/11/00 | 9/11/00 | 3/28/04 |
| Renova Indications: For the mitigation (palliation) of fine facial wrinkles in patients who use comprehensive skin care and sunlight avoidance programs. | ||||||
| Renova (tretionin) Cream, 0.05%, Rx | Johnson and Johnson Consumer Industries, Inc. | NDA 19-963/SE8-005 & SLR-007 | 8/1/00 | 8/9/00 | 8/9/00 | |
| Renova Indications:An adjunctive agent for the use in mitigation (palliation) of fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin in patients who use comprehensive skin care and sunlight avoidance programs. | ||||||
| ReoPro (Abciximab) | Centocor B.V. | BLA 103575/5025 | 11/21/03 | 12/4/03 | ||
| ReoPro (Abciximab) | Centocor B.V. | BLA 103575/5022 | 11/21/03 | 12/4/03 | ||
| Repronex (menotropins for injection), 75 and 150 IU injection, Rx | Ferring Pharmaceuticals, Inc. | NDA 21-047 | 08/27/99 | 9/2/99 | 9/2/99 | |
| Repronex Indication: for use in conjunction with hCG for multiple follicular development and ovulation induction in patients who have previously received pituitary suppression | ||||||
| Requip (ropinirole hydrochloride) Tablets, | GlaxoSmithKline | NDA 20-658 / S012 | 6/19/03 | 7/8/03 | ||
| Rescriptor (delavirdine) Tablet, 100 & 200mg | Agouron Pharmaceuticals Inc. | 20-705/S-009 | 3/14/02 | 3/29/02 | ||
| Rescriptor (delavirdine mesylate) Tablet, | Agouron Pharmaceuticals Inc. | NDA 20-705/S-008 | 5/16/01 | 7/24/03 | 5/16/01 | |
| Rescriptor (delavirdine mesylate) Tablet, 200mg | Pharmacia & Upjohn Company | 20-705/S-003 | 7/14/99 | 7/28/99 | 7/28/99 | 3/24/04 |
| Rescriptor Indication:For the treatment of HIV-1 infection in combination with appropriate antiretroviral agents. | ||||||
| Rescula (unoprostone isopropyl) Ophthalmic Solution, 0.15%, Rx | Ciba Vision | NDA 21-214 | 8/3/00 | 8/28/00 | 8/28/00 | 7/18/01 |
| Rescula Indications: for the lowering of intraocular pressure in patients with open-angel glaucoma or ocular hypertension who are intolerant of other intraocular pressure lowering medications or insufficiently responsive (failed to achieve target IOP determined after multiple measurements over time) to another intraocular pressure lowering medication. | ||||||
| Restasis (cyclosporine) Ophthalmic Emulsion, 0.05%, Rx | Allergan, Inc. | NDA 50-790/S3 & S4 | 10/1/03 | 10/10/03 | ||
| Restasis (cyclosporine) Ophthalmic Emulsion, 0.05%, Rx | Allergan, Inc. | NDA 50-790/S1 | 9/16/03 | 9/25/03 | 9/26/03 | |
| Restasis (cyclosporine) Ophthalmic Emulsion, 0.05%, Rx | Allergan, Inc. | NDA 50-790 | 12/23/02 | 1/29/03 | 9/8/03 | |
| Restoril Capsules, 7.5 mg, 15 mg, and 30 mg, | Mallinckrodt Inc. | NDA 18-163/S-053 | 5/31/02 | 6/3/02 | ||
| Retin-A (tretinoin) Liquid, Cream, 0.1%, Cream, 0.05%, Gel, 0.025%, Gel, 0.01%, and Cream, 0.025%., | Johnson & Johnson Consumer Companies, Inc. | NDA 16-921 S021/022/025, 17-340 S032/033/036, 17-522 S022/023/026, 17-579 S018/020/023, 17-955 S019/020/023, & 19-049 S007/008/011 | 6/10/02 | 6/14/02 | 6/12/02 | |
| Retin-A MICRO (tretinoin gel) microspheres, 0.04% | Johnson & Johnson Consumer Companies, Inc | NDA 20-475/S-008 | 5/10/02 | 5/21/02 | 5/14/02 | |
| RETROVIR (zidovudine) IV Infusion, | GlaxoSmithKline | NDA 19-951/S-019 | 7/25/03 | 8/15/03 | 8/15/03 | |
| RETROVIR (zidovudine) IV Infusion | GlaxoSmithKline | NDA 19-951/S-018 | 7/25/03 | 8/6/03 | 8/6/03 | |
| RETROVIR (zidovudine) IV Infusion | GlaxoSmithKline | NDA 19-951/S-017 | 2/21/02 | 2/21/02 | ||
| RETROVIR (zidovudine) IV Infusion | GlaxoSmithKline | NDA 19-951/S-016 | 9/12/01 | 6/10/03 | ||
| RETROVIR (zidovudine) Capsules, Syrup, & Tablets, | GlaxoSmithKline | NDA 19-655/S039, 19-910/S027, & 20-528/S011 | 10/15/03 | 10/17/03 | 10/17/03 | |
| RETROVIR (zidovudine) Capsules, Syrup, & Tablets, | GlaxoSmithKline | NDA 19-655/S038, 19-910/S026, & 20-518/S010 | 12/18/02 | 1/29/03 | 4/4/03 | |
| RETROVIR (zidovudine) Capsules, Syrup, & Tablets. | GlaxoSmithKline | NDA 19-655/S037, 19-910/S025, & 20-518/S009 | 2/21/02 | 2/21/02 | ||
| RETROVIR (zidovudine) Capsules, Syrup, & Tablets. | GlaxoSmithKline | NDA 19-655/S036 | 10/5/01 | 6/16/03 | ||
| RETROVIR (zidovudine) Capsules, Syrup, & Tablets. | GlaxoSmithKline | NDA 19-655/S032, 19-910/S021, 20-518/S004 | 3/30/01 | 4/26/01 | 4/26/01 | |
| RETROVIR (zidovudine) Capsules, Syrup, & Tablets. | GlaxoSmithKline | NDA 20-518/S8 | 10/5/01 | 4/25/01 | ||
| REYATAZ (atazanavir) Capsules, 100, 150 and 200mg | Bristol-Myers Squibb | NDA 21-567/S1 | 3/16/04 | 3/19/04 | 4/6/04 | |
| REYATAZ (atazanavir) capsules, 100mg, 150mg and 200mg | Bristol-Myers Squibb | NDA 21-567 | 6/20/03 | 8/6/03 | 7/8/03 | 9/9/03 |
| Rezulin (troglitazone) Tablets, 200mg, 300mg, & 400mg, Rx only | Parke-Davis | NDA 20-720/ S-012 /S-014 | 6/16/99 | 6/17/99 | 6/17/99 | 7/3/00 |
| Rezulin Indication: Supplement 012 provides for the use of Rezulin in combination with metformin and sulfonylures in patients with type 2 diabetes. | ||||||
| Rhinocort Aqua (budesonide) Nasal Spray, Rx | AstraZeneca | NDA 20-746/S13 | 1/16/04 | 1/22/04 | 1/22/04 | |
| Rhinocort Aqua (budesonide) Nasal Spray, Rx | AstraZeneca | NDA 20-746 | 10/1/99 | 10/4/99 | 10/4/99 | 6/19/01 |
| Rhinocort Aqua (budesonide) Nasal Spray, Rx | AstraZeneca LP | NDA 20-746/S4 | 10/26/01 | 11/6/01 | ||
|
Rhinocort Indicated:
for the management of nasal symptoms of seasonal or perennial allergic rhinitis in adults and children six years of age and older. |
||||||
| Ribasphere (Ribavirin)
Capsules, 200mg, Rx exclusivity letter |
Three River Pharmaceuticals | ANDA 76-203 | 4/7/04 | 4/7/04 | 4/9/04 | |
| Ribavirin
Capsules, 200mg, Rx exclusivity letter |
Sandoz, Inc. | ANDA 76-192 | 4/7/04 | 4/7/04 | 4/9/04 | |
| Rid Mousse, [pyrethrum extract (equivalent to 0.33% pyrethrins) and 4% piperonyl butoxide], OTC | Soltec Research | NDA 21-043 | 3/7/00 | 3/9/00 | 3/9/00 | 4/30/02 |
| Rid Mousse Indications: Treatment of head, pubic (crab), and body lice | ||||||
| Rifampin Capsules USP,150 mg & 300 mg/vial, Rx | VersaPharm Inc. | ANDA 65-028 | 3/14/01 | 3/30/01 | ||
| Rifampin for Injection USP, 600 mg/vial, Rx | Bedford Laboratories | ANDA 64-217 | 10/29/99 | 12/30/99 | 1/16/02 | |
| Riluzole Tablets, 50 mg, Rx | IMPAX Laboratories, Inc. | ANDA 76-173 | 7/17/02 | |||
| Riluzole Tablets, 50 mg, Rx Tentatively Approved | IMPAX Laboratories, Inc. | ANDA 76-173 | 7/17/02 | |||
| Rimantadine Hydrochloride Tablets, 100 mg, Rx | Amide Pharmaceutical, Inc. | ANDA 76-375 | 1/14/03 | |||
| Rimantadine Hydrochloride Tablets, 100 mg, Rx | Impax Laboratories | ANDA 76-132 | 8/30/02 | |||
| Rimantadine Hydrochloride Tablets, 100 mg, Rx | Corepharma, LLC | ANDA 75-916 | 11/02/01 | 4/16/03 | ||
| Riomet (Metformin HCI) Oral Solution, Rx | Ranbaxy | NDA 21-591 | 9/11/03 | 9/25/03 | 9/26/03 | |
| Risperdal (risperidone) tablets, oral solution & orally disintegrating tablets, Rx | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | NDA 20-272/S33, 20-588/21 & 21-444/S4 | 9/10/03 | 9/25/03 | ||
| Risperdal (risperidone) orally disintegrating tablets, Rx | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | NDA 21-444 | 4/2/03 | 7/15/03 | ||
| Risperdal (risperidone) Tablets, Oral Solution & Disintegrating Tablets, Rx | Johnson & Johnson | NDA 20-272/S26 & S27, 20-588/S17 & S18 & 21-444/S2 & S3 | 12/4/03 | 12/11/03 | 12/11/03 | |
| Risperdal (risperidone) Tablets & Oral Solution, Rx | Johnson & Johnson | NDA 20-272/S25, 20-588/S16 & 21-444/S5 | 10/29/03 | 11/28/03 | ||
| Risperdal (risperidone) Tablets & Oral Solution, Rx | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | NDA 20-588/ SE5-015 & 20-272/ SE5-024 | 11/19/02 | 11/22/02 | ||
| Risperdal (risperidone) Tablets, Rx | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | NDA 20-588/ SE5-004 & 20-272/ SE5-008 | 3/3/02 | 3/12/02 | ||
| Risperdal (risperidone) Tablets, Oral Solution, and M-TAB Orally Disintegrating, Rx | Janssen | NDA 20-272/S35, 20-588/ S23 & 20-444/S7 | 11/21/03 | 11/28/03 | ||
| Risperdal (risperidone) Tablets, Rx | Janssen | NDA 20-588/ SE5-005 & 20-272/ SE5-009 | 7/2/99 | 7/2/99 | 7/2/99 | |
| Rezulin Indication: Change in labeling to expand Geriatric Use | ||||||
| Risperdal Consta (risperidone) Long -Acting Injection, | Johnson & Johnson | NDA 21-346 | 10/29/03 | 11/28/03 | ||
| Risperidone Tablets, Rx | Mylan Pharmaceuticals | ANDA 76-288 | 3/31/04 | |||
| Ritalin LA (methylphenidate hydrochloride) ER Capsules, Rx | Novartis Pharmaceuticals Corporation | NDA 21-284/S4 | 4/8/04 | |||
| Ritalin LA (methylphenidate hydrochloride) Extended-release Capsules, Rx | Novartis Pharmaceuticals Corporation | NDA 21-284 | 6/5/02 | 6/17/02 | 6/7/02 | 11/20/02 |
| Ritalin (methylphenidate hydrochloride) and Ritalin-SR Sustained-release Tablets | Novartis Pharmaceuticals Corporation | NDA 10-187/S-060 & 18-029/S-032 | 1/11/02 | 2/8/02 | ||
| Rituxan Rituximab | IDEC Pharmaceuticals Corp | BLA 103737 / 5023 | 10/9/03 | 11/3/03 | ||
| Robaxin (methocarbamol) Tablets, 500 mg and 750 mg, Rx | Schwarz Pharma, Inc. | NDA 11-011/S70 & S71 | 5/1/03 | 7/9/03 | ||
| Robaxisol (methocarbamol and aspirin) Tablets, | Wyeth Pharmaceuticals | NDA 12-281/S50, S51 & S52 | 2/10/04 | 3/3/04 | ||
| Robinul Forte (glycopyrrolate) Tablets, | First Horizon Pharmaceutical | NDA 12-827/S-049 | 7/25/03 | 8/6/03 | ||
| Robinul & Robinul Forte (glycopyrrolate) Tablets, | First Horizon Pharmaceutical | NDA 17-558/S-049 | 7/25/03 | |||
| Robinul (glycopyrrolate) Injectable, | Baxter Healthcare | NDA 17-558/S-047, S-048 | 6/30/03 | 7/6/03 | ||
| Rocaltrol (calcitriol) Capsules & Oral Solution, | Hoffmann-LaRoche Inc. | NDA 18-044/S28 & 21-068/S1 | 2/1/02 | 4/17/02 | ||
| Rocaltrol (calcitriol)1mcg/mL oral solution | Hoffman LaRoche | NDA 21-068 and 18-044/S-025 | 11/20/98 | 11/20/98 | ||
| Rocaltrol (calcitriol) Oral Solution (3S) | Roche Biolscience | NDA 21-068 | 11/20/98 | 11/23/98 | 11/23/98 | 7/4/99 |
| Rocaltrol Indication: Indication is for the management of secondary hyperparathyroidism and resultant metabolic bone disease in predialysis (moderate to severe chronic renal failure) patients (adults, neonates, and older infants). | ||||||
| Rocephin (ceftriaxone sodium) Injection, | Hoffman-La Roche Inc. | NDA 50-585/S-054 | 3/29/04 | 4/7/04 | 4/6/04 | |
| Rogaine for Men Extra Strength (minoxidil topical solution), 5% | Pharmacia Consumer Healthcare | NDA 20-834/S-003 | 2/14/03 | 2/25/03 | 5/29/03 | |
| Romazicon (flumazenil) Injection, | Hoffman-La Roche Inc. | NDA 20-073/S-011 | 3/3/04 | 3/10/04 | 3/5/04 | |
| Roxicodone Tablets, 15 mg and 30 mg, Rx | Roxane Laboratories | NDA 21-011 | 8/31/00 | 9/11/00 | 9/11/00 | 3/10/04 |
| Roxicodone (oxycodone hydrochloride) Sustained Release Tablets, 10 mg and 30 mg, Rx | Roxane Laboratories | NDA 20-932 | 10/26/98 | 10/28/98 | 7/8/99 | |
| Roxicodone Indication: Indication is for the management of moderate-to-severe pain where use of an opioid analgesic is appropriate for more than a few days. | ||||||
| Rufludan [lepirudin (rDNA)] Injection, Rx | Berlex Laboratories, Inc. | NDA 20-807/S-005 | 4/2/03 | 4/18/03 | ||
| Rythmol SR (propafenone HCl) Capsules, Rx | Abbott Laboratories | NDA 21-416 | 9/4/03 | 9/25/03 | 9/25/03 | 2/11/04 |
| Rythmol (propafenone HCl) Tablets, 150, 225 and 300 mg, Rx | Abbott Laboratories | NDA 19-151/S-005 & S-009 | 12/5/02 | 1/29/03 | ||
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