Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Drug Recalls For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

FDA Approval Activities for this Drug… Nifedipine Extended-release Tablets, 90 mg. , Biovial ANDA 76-070 8/16/02 Nifedipine Extended-release Tablets, 60 mg. ,Rx (Tentatively approved 3/20/01) Elan Pharmaceutical Research Corp. ANDA 75-659 3/20/01 3/30/01 Nifedipine Extended-release Tablets, 30 mg. ,Rx Biovail ANDA 75-289/S1 2/6/01 3/6/01 Nifedipine Extended-release Tablets, 60 mg. ,Rx, 30mg strength remains Biovail ANDA 75-289 9/28/00 10/30/00 Nifedipine Extended-release Tablets, 30 mg & 60 mg. ,Rx (Tentatively approved 7/24/00) Biovail ANDA 75-289 7/24/00 10/30/00 Nifedipine Extended-release Tablets, 30 mg & 60 mg., Biovail ANDA 75-269 12/4/00 2/28/01 Nifedipine Extended-release Tablets, 30 mg & 60 mg. (Tentatively approved 6/29/99) Biovail ANDA 75-269 6/29/99 6/30/99 Nifedipine Extended-release Tablets, 30 mg., Elan Pharmaceutical ANDA 75-128 3/10/00 3/15/00 Nifedipine Extended-release Tablets, 30 mg. (Tentatively Approved 5/28/99) Elan Pharmaceutical ANDA 75-128 5/28/99 6/1/99 Nifedipine Extended-release Tablets, 30 mg (Tentatively approved 3/15/99) Mylan ANDA 75-108 3/15/99 3/16/99 Nifedipine Extended-release Tablets, 30 mg Mylan ANDA 75-108 Procardia (nifedipine) Capsules, Pfizer NDA 18-482/S43 NIFEDIPINE Capsule; 10MG NIFEDIPINE FLEMINGTON 018482 NIFEDIPINE Capsule; 10MG PROCARDIA PFIZER 018482 NIFEDIPINE Capsule; 20MG PROCARDIA PFIZER 072579 NIFEDIPINE Capsule; 10MG NIFEDIPINE Purepac 072556 NIFEDIPINE Capsule; 20MG NIFEDIPINE Purepac 073250 NIFEDIPINE Capsule; 10MG NIFEDIPINE SCHERER RP 074045 NIFEDIPINE Capsule; 20MG NIFEDIPINE SCHERER RP 072651 NIFEDIPINE Capsule; 10MG NIFEDIPINE Teva 020198 AB1 NIFEDIPINE Tablet, Extended Release; 30MG ADALAT CC BAYER 020198 AB1 NIFEDIPINE Tablet, Extended Release; 60MG ADALAT CC BAYER 020198 AB1 NIFEDIPINE Tablet, Extended Release; 90MG ADALAT CC BAYER 075269 AB1 NIFEDIPINE Tablet, Extended Release; 30MG NIFEDIPINE BIOVAIL 075289 AB2 NIFEDIPINE Tablet, Extended Release; 30MG NIFEDIPINE BIOVAIL 075269 AB1 NIFEDIPINE Tablet, Extended Release; 60MG NIFEDIPINE BIOVAIL 075289 AB2 NIFEDIPINE Tablet, Extended Release; 60MG NIFEDIPINE BIOVAIL 076070 AB1 NIFEDIPINE Tablet, Extended Release; 90MG NIFEDIPINE BIOVAIL 075128 AB1 NIFEDIPINE Tablet, Extended Release; 30MG NIFEDIPINE ELAN 075659 AB1 NIFEDIPINE Tablet, Extended Release; 60MG NIFEDIPINE ELAN 019684 AB2 NIFEDIPINE Tablet, Extended Release; 30MG PROCARDIA XL PFIZER 019684 AB2 NIFEDIPINE Tablet, Extended Release; 60MG PROCARDIA XL PFIZER 019684 BC NIFEDIPINE Tablet, Extended Release; 90MG PROCARDIA XL PFIZER Nifedipine Extended-release Tablets, Martec Scientific | ADALAT CC (nifedipine) Extended Release Tablets, Bayer Pharma, Labeling Revision | Nifedipine Extended-Release Tablets, Abrika Pharma, Approval | Nifedipine Extended-Release Tablets, Osmotica Pharma, Tentative Approval | Nifedipine Capsules, Actavis, Control Suppl. | Nifedipine Extended-release Tablets, Osmotica Pharma, Approval ^ FDA's latest approval appears at the bottom of this list. ^   A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | News Feed for each API | DMF Index | Pharma Job Search | Pharma Company News © 2008 Betterchem.com