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FDA Approval Activities for this Drug… Norvasc (amlodipine besylate) Tablets, 2.5, 5, & 10 mg, Rx Pfizer Inc. NDA 19-787/S032 5/24/02 6/3/02 Norvasc (amlodipine besylate) Tablets, 2.5, 5, & 10 mg, Rx Pfizer Inc. NDA 19-787/S031 8/20/03 8/28/03 Norvasc (amlodipine besylate) Tablets, 2.5, 5, & 10 mg, Rx Pfizer Inc. NDA 19-787/S30 1/8/04 1/9/04 Norvasc (amlodipine besylate) Tablets, 2.5, 5, & 10 mg, Rx Pfizer Inc. NDA 19-787/S27 12/3/03 12/8/03 Norvasc (amlodipine besylate) Tablets, 2.5, 5, & 10 mg, Rx Pfizer Inc. NDA 19-787/S022 12/15/99 6/22/01 Norvasc (amlodipine besylate) Tablets, Rx Pfizer NDA 19-787/S021 2/1/00 6/6/01 Norvasc (amlodipine besylate) Tablets, 2.5, 5, & 10 mg, Rx Pfizer Inc. NDA 19-787/S019 9/7/99 8/6/03 Norvasc (amlodipine besylate) Tablets, 2.5, 5, & 10 mg, Rx Pfizer Inc. NDA 19-787/S018 6/4/99 6/22/01 Norvasc (amlodipine besylate) Tablets, Rx Pfizer NDA 19-787/S017 & S020 7/12/00 7/14/00 6/4/01 Norvasc Indications: Supplement provided for extensive revisions of the PRECAUTIONS: Drug Interactions subsection AMLODIPINE BESYLATE TABLET; ORAL EQ 10MG BASE NORVASC PFIZER | 019787 No AMLODIPINE BESYLATE TABLET; ORAL EQ 2.5MG BASE NORVASC PFIZER | 019787 No AMLODIPINE BESYLATE TABLET; ORAL EQ 5MG BASE NORVASC PFIZER | 021540 No AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET; ORAL EQ 10MG BASE;EQ 10MG BASE CADUET PFIZER | 021540 No AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET; ORAL EQ 10MG BASE;EQ 20MG BASE CADUET PFIZER | 021540 No AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET; ORAL EQ 10MG BASE;EQ 40MG BASE CADUET PFIZER 021540 Yes AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET; ORAL EQ 10MG BASE;EQ 80MG BASE CADUET PFIZER | 021540 No AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET; ORAL EQ 5MG BASE;EQ 10MG BASE CADUET PFIZER | 021540 No AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET; ORAL EQ 5MG BASE;EQ 20MG BASE CADUET PFIZER | 021540 No AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET; ORAL EQ 5MG BASE;EQ 40MG BASE CADUET PFIZER 021540 No AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET; ORAL EQ 5MG BASE;EQ 80MG BASE CADUET PFIZER | 020364 Yes AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE CAPSULE; ORAL EQ 10MG BASE;20MG LOTREL NOVARTIS | 020364 No AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE CAPSULE; ORAL EQ 2.5MG BASE;10MG LOTREL NOVARTIS | 020364 No AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE CAPSULE; ORAL EQ 5MG BASE;10MG LOTREL NOVARTIS | 020364 No AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE CAPSULE; ORAL EQ 5MG BASE;20MG LOTREL NOVARTIS | Lotrel (amlodipine and benazepril HCl) Capsules, 2.5/10mg, 5/10 mg, and 5/20 mg, Rx Novartis Pharmaceuticals Corporation NDA 20-364/S-016 6/20/02 6/24/02 11/18/02 11/22/02 Lotrel (amlodipine and benazepril HCl) Capsules, Rx Novartis Pharmaceuticals Corporation NDA 20-364/S-014 8/29/03 9/9/03 Lotrel (Amiodipine Besylate/Benazepril Hydrochloride) Capsules Novartis Pharmaceuticals Corp. NDA 20-364/S008 6/16/99 8/21/01 Lotrel (amlodipine and benazepril HCl) Capsules, Novartis Pharmaceuticals Labeling Revision Lotrel (amlodipine besylate and benazepril hydrochloride) Capsules, Novartis Pharmaceuticals, Labeling Revision | Caduet (amlodipine besylate/atorvastatin calcium) Tablets, Pfizer Inc., Supplement | Amlodipine Besylate Tablets, Apotex, Tentative Approval | Amlodipine Besylate Tablets, TEVA Pharma, Tentative Approval | Amlodipine Besylate Tablets, Watson Labs, Tentative Approval | Norvasc (amlodipine besylate) Tablets, Pfizer Inc., Labeling Revision | Amlodipine Besylate Tablets, Roxane Labs, Tentative Approval | Amlodipine Besylate Tablets, Mylan Pharma, Approval | Amlodipine Besylate Tablets, Dr. Reddy's Labs, Tentative Approval | Lotrel (amlodipine besylate and benazepril HCl) Capsules, Novartis Pharma, New Dosage Regimen | Caduet (amlodipine besylate and atorvastatin calcium) Tablets, Pfizer, Labeling Revision | Amlodipine Besylate Tablets, Kali Labs, Tentative Approval | Caduet Tablet, Pfizer, Labeling Revision | Amlodipine Maleate/Benazepril Hydrochloride Capsules, Dr. Reddy’s Labs, Tentative Approval | Exforge (amlodipine and valsartan) Tablets, Novartis Pharma, Tentative Approval | Lotrel (amlodipine besylate and benazepril HCl) Capsules, Novartis Pharma, Labeling Revision | Amlodipine Besylate Tablets, Matrix Labs, Tentative Approval Visit Betterchem's Drug Index for FDA's latest approval information.   Find other drugs… 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 | USActives.com | Pharma Job Search | Pharma Company News © 2011 FindingHealthOnline™