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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
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