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FDA Approval Activities for this Drug…
Ranitidine Capsules, 150 mg. & 300 mg., Cheminor Drugs Limited ANDA 75-742 11/29/00 3/5/01 Ranitidine Capsules, 150 mg. & 300 mg., Approvable Teva 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., Genpharm ANDA 75-564 10/27/00 11/6/00 Ranitidine Tablets USP, 75 mg., OTC Geneva ANDA 75-519 9/26/02 Ranitidine Tablets USP, 75 mg, OTC Genpharm ANDA 75-497 1/14/00 2/4/00 Ranitidine Tablets USP, 150 mg and 300 mg, Ranbaxy, Ltd. ANDA 75-439 4/19/00 4/24/00 Ranitidine Tablets USP 75 mg Tablets, OTC Zenith Goldline ANDA 75-296 1/14/00 2/4/00 Ranitidine Tablets USP, 75 mg., Tablets, OTC 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 : 10/5/1998 Chelsea ANDA 75-212 10/5/98 10/5/98 Ranitidine Tablets USP, 75 mg, OTC : 11/29/1999 Chelsea ANDA 75-212 11/29/99 12/29/99 Ranitidine Tablets USP 75 mg Tablets, OTC Chelsea , ANDA 75-212 1/14/00 1/24/00 Ranitidine Tablets USP, 150 mg and 300 mg, Wockhardt Americas, ANDA 75-208 12/17/98 12/22/98 Ranitidine Tablets USP, 150 mg and 300 mg, Par Pharmaceutical, ANDA 75-180 1/28/99 1/28/99 Ranitidine Tablets USP,75 mg, OTC : 9/29/1998 Torpharm ANDA 75-167 9/29/98 9/29/98 Ranitidine Tablets USP,75 mg., : 4/8/1999 Apotex Corp. ANDA 75-167 4/8/99 4/16/99 Ranitidine Tablets USP, 75 mg, OTC Torpharm, ANDA 75-167 5/4/00 5/22/00 Ranitidine Tablets USP, 150 mg and 300 mg, Zenith ANDA 75-165 9/30/98 9/30/98 Rantidine Tablets USP,75 mg : 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, : 1/26/1999 Novopharm N.C. ANDA 75-094 1/26/99 1/26/99 Ranitidine Tablets USP, 150 mg (base) & 300 mg (base). Ranbaxy ANDA 75-000 1/30/98 3/19/99 Ranitidine Tablets USP, 150 mg (base) and 300 mg (base), Mylan ANDA 74-552 Zantac (ranitidine hydrochloride) Efferdose Glaxo Wellcome, NDA 20251/S-6 10/29/99 4/25/03 Zantac (ranitidine hydrochloride) Injection Glaxo Wellcome, 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, NDA 20520/S-001 RANITIDINE HYDROCHLORIDE Capsule; 150MG BASE RANITIDINE HCL DR REDDYS LTD 075742 RANITIDINE HYDROCHLORIDE Capsule; 300MG BASE RANITIDINE HCL DR REDDYS LTD 074655 RANITIDINE HYDROCHLORIDE Capsule; 150MG BASE RANITIDINE HCL Geneva 074655 RANITIDINE HYDROCHLORIDE Capsule; 300MG BASE RANITIDINE HCL Geneva 075564 RANITIDINE HYDROCHLORIDE Capsule; 150MG BASE RANITIDINE HCL Genpharm 075564 RANITIDINE HYDROCHLORIDE Capsule; 300MG BASE RANITIDINE HCL Genpharm 020251 RANITIDINE HYDROCHLORIDE Granule, Effervescent; 150MG BASE/PACKET ZANTAC 150 GLAXOSMITHKLINE 019593 RANITIDINE HYDROCHLORIDE Injection 1MG BASE/ML ZANTAC IN PLASTIC CONTAINER GLAXOSMITHKLINE 019090 RANITIDINE HYDROCHLORIDE Injection 25MG BASE/ML ZANTAC GLAXOSMITHKLINE 019675 RANITIDINE HYDROCHLORIDE Syrup; 15MG BASE/ML ZANTAC GLAXOSMITHKLINE 020251 RANITIDINE HYDROCHLORIDE Tablet, Effervescent; 150MG BASE ZANTAC 150 GLAXOSMITHKLINE 074467 RANITIDINE HYDROCHLORIDE Tablet; 150MG BASE RANITIDINE HCL Geneva 074467 RANITIDINE HYDROCHLORIDE Tablet; 300MG BASE RANITIDINE HCL Geneva 074023 RANITIDINE HYDROCHLORIDE Tablet; 150MG BASE RANITIDINE HCL Genpharm 074023 RANITIDINE HYDROCHLORIDE Tablet; 300MG BASE RANITIDINE HCL Genpharm 018703 RANITIDINE HYDROCHLORIDE Tablet; 150MG BASE ZANTAC 150 GLAXOSMITHKLINE 018703 RANITIDINE HYDROCHLORIDE Tablet; 300MG BASE ZANTAC 300 GLAXOSMITHKLINE 075165 RANITIDINE HYDROCHLORIDE Tablet; 150MG BASE RANITIDINE HCL Ivax 075165 RANITIDINE HYDROCHLORIDE Tablet; 300MG BASE RANITIDINE HCL Ivax 074552 RANITIDINE HYDROCHLORIDE Tablet; 150MG BASE RANITIDINE HCL Mylan 074552 RANITIDINE HYDROCHLORIDE Tablet; 300MG BASE RANITIDINE HCL Mylan 075180 RANITIDINE HYDROCHLORIDE Tablet; 150MG BASE RANITIDINE HCL Par 075180 RANITIDINE HYDROCHLORIDE Tablet; 300MG BASE RANITIDINE HCL Par 075000 RANITIDINE HYDROCHLORIDE Tablet; 150MG BASE RANITIDINE HCL Ranbaxy 075439 RANITIDINE HYDROCHLORIDE Tablet; 150MG BASE RANITIDINE Ranbaxy 075439 RANITIDINE HYDROCHLORIDE Tablet; 300MG BASE RANITIDINE Ranbaxy 075000 RANITIDINE HYDROCHLORIDE Tablet; 300MG BASE RANITIDINE HCL Ranbaxy 074488 RANITIDINE HYDROCHLORIDE Tablet; 150MG BASE RANITIDINE HCL Teva 074488 RANITIDINE HYDROCHLORIDE Tablet; 300MG BASE RANITIDINE HCL Teva 074680 RANITIDINE HYDROCHLORIDE Tablet; 150MG BASE RANITIDINE HCL Torpharm 074680 RANITIDINE HYDROCHLORIDE Tablet; 300MG BASE RANITIDINE HCL Torpharm 074864 RANITIDINE HYDROCHLORIDE Tablet; 150MG BASE RANITIDINE HCL Watson 074864 RANITIDINE HYDROCHLORIDE Tablet; 300MG BASE RANITIDINE HCL Watson 075208 RANITIDINE HYDROCHLORIDE Tablet; 150MG BASE RANITIDINE HCL Wockhardt 075208 RANITIDINE HYDROCHLORIDE Tablet; 300MG BASE RANITIDINE HCL Wockhardt Zantac (ranitidine hydrochloride) Efferdose, GlaxoSmithKline Zantac, GlaxoSmithKline Zantac 150 (ranitidine hydrochloride) tablets, Pfizer, Approval | Ranitidine Injection, Bedford Labs, Approval | Zantac 75 (75mg ranitidine) Tablets, Consumer Healthcare, Labeling Revision | Ranitidine Injection, BenVenue Labs, Approval | Zantac (ranitidine hydrochloride) Tablets, GlaxoSmithKline, Labeling Revision | Zantac (ranitidine hydrochloride) Syrup, GlaxoSmithKline, Labeling Revision | Zantac EFFERdose Tablets & Granules, GlaxoSmithKline, Labeling Revision | Ranitidine Tablets, Dr. Reddy's Labs, Approval | Ranitidine Tablets, Wockhardt, Approval | Ranitidine Tablets, Interpharm, Inc., Approval | Ranitidine Syrup Oral Solution, Alpharma, Approval | Ranitidine Syrup Oral Solution, Taro Pharma, Tentative Approval | Zantac 150 (Ranitidine) Tablets, Boehringer Ingelheim, Formulation Revision | Ranitidine Syrup, Pharma Assoc., Tentative Approval
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