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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 AMLODIPINE BESYLATE TABLET; ORAL EQ 2.5MG BASE NORVASC PFIZER | 019787 AMLODIPINE BESYLATE TABLET; ORAL EQ 5MG BASE NORVASC PFIZER | 021540 AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET; ORAL EQ 10MG BASE;EQ 10MG BASE CADUET PFIZER | 021540 AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET; ORAL EQ 10MG BASE;EQ 20MG BASE CADUET PFIZER | 021540 AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET; ORAL EQ 10MG BASE;EQ 40MG BASE CADUET PFIZER 021540 AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET; ORAL EQ 10MG BASE;EQ 80MG BASE CADUET PFIZER | 021540 AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET; ORAL EQ 5MG BASE;EQ 10MG BASE CADUET PFIZER | 021540 AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET; ORAL EQ 5MG BASE;EQ 20MG BASE CADUET PFIZER | 021540 AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET; ORAL EQ 5MG BASE;EQ 40MG BASE CADUET PFIZER 021540 AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET; ORAL EQ 5MG BASE;EQ 80MG BASE CADUET PFIZER | 020364 AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE CAPSULE; ORAL EQ 10MG BASE;20MG LOTREL NOVARTIS | 020364 AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE CAPSULE; ORAL EQ 2.5MG BASE;10MG LOTREL NOVARTIS | 020364 AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE CAPSULE; ORAL EQ 5MG BASE;10MG LOTREL NOVARTIS | 020364 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 | Amlodipine Besylate Tablets, Gedeon Richter, Tentative ApprovalAmlodipine Besylate Tablets, Genpharm Inc., Tentative Approval | Amlodipine Besylate and Benazepril Hydrochloride Capsules, Teva Pharma, Approval | Amlodipine Besylate Tablets, Apotex Inc., Approval | Amlodipine Besylate Tablets, Zydus Pharma, Tentative Approval | Exforge (amlodipine and valsartan) Tablets, Novartis Pharma, Approval | Amlodipine Besylate Tablets, Synthon Labs, Approval | Amlodipine Besylate Tablets, Teva Pharma, Approval | Amlodipine Besylate Tablets, Upsher-Smith, Approval | Amlodipine Besylate Tablets, Ranbaxy Inc., Approval | Amlodipine Besylate Tablets, Roxane Labs, Approval | Amlodipine Besylate Tablets, Genpharm Inc., Approval | Amlodipine Besylate Tablets, Zydus Pharma, Approval | Amlodipine Besylate Tablets, Gedeon Richter, Approval | Amlodipine Besylate Tablets, Aurobindo Pharma, Approval | Amlodipine Besylate Tablets, Kali Labs, Approval | Amlodipine Besylate Tablets, Lupin Pharma, Approval | Amlodipine Besylate Tablets, Cobalt Pharma, Approval | Amlodipine Besylate Tablets, Dr. Reddy’s Labs, Approval | Lotrel (benazepril hydrochloride/amlodipine besylate) Capsules, Novartis Pharma, Control Supplement | Amlodipine Besylate Tablets, Actavis, Approval | Amlodipine Besylate Tablets, Wockhardt, Approval | Amlodipine Besylate Tablets, Lek Pharma, Approval | Caduet (amlodipine besylate and atorvastatin calcium) Tablets, Pfizer Inc., Labeling Revision | Amlodipine Orally Disintegrating Tablets, Synthon Pharma, Approval | Amlodipine Besylate Tablets, Watson Labs, Approval | AZOR (amlodipine and olmesartan medoxomil) Tablets, Daiichi Sankyo, Approval | Norvasc (amlodipine besylate) Tablets, Pfizer Inc., Labeling Revision | Amlodipine Besylate and Benazepril Hydrochloride Capsules, Watson Labs, Tentative Approval | Amlodipine Besylate Tablets, Caraco Pharma, Approval | Amlodipine Besylate Tablets, Interpharm Inc., Approval | Amlodipine Besylate Tablets, Mutual Pharma, Approval | Amlodipine Besylate Tablets, Mylan Pharma, Approval | Amlodipine Besylate and Benazepril Hydrochloride Capsules, Kali Labs, Tentative Approval | Caduet (amlodipine besylate and atorvastatin calcium) Tablets, Pfizer Global Pharmaceuticals, Inc., Labeling Revision | Exforge (amlodipine besylate and valsartan) Tablets, Novartis Pharmaceuticals Corp., New or Modified Indication | Azor (amlodipine besylate and olmesartan medoxomil) Tablets, Daiichi Sankyo, Inc., Labeling Revision | Amlodipine Besylate Tablets, Torrent Pharmaceuticals, Ltd., Approval | Amlodipine Besylate Tablets, Glenmark Generics, Ltd., Approval | Amlodipine Besylate Tablets, Alkem Laboratories Ltd., Approval | Exforge HCT (amlodipine, valsartan and hydrochlorothiazide) Tablets, Novartis Pharmaceuticals Corp., Approval | Azor (amlodipine besylate and olmesartan medoxomil) Tablets, Daiichi Sankyo Pharma Development, New or Modified Indication | Amlodipine Besylate Tablets, Orchid Healthcare, Approval | Amlodipine Besylate and Benazepril Hydrochloride Capsules, Mylan Pharmaceuticals Inc., Tentative Approval | Caduet (amlodipine besylate and atorvastatin calcium) Tablets, Pfizer Global Pharmaceuticals, Labeling Revision | Lotrel (amlodipine besylate and benazepril hydrochloride) Capsules, Novartis Pharmaceuticals Corporation, Labeling Revision | Amlodipine besylate/Benazepril hydrochloride Capsules, Novartis Pharmaceuticals Corporation, Manufacturing Change or Addition | Amlodipine and Valsartan Tablets, Matrix Laboratories Ltd., Tentative Approval | Amlodipine Besylate and Benazepril Hydrochloride Capsules, Cobalt Laboratories Inc., Tentative Approval | Norvasc (amlodipine besylate) Tablets, Pfizer Inc., Labeling Revision | Amlodipine Besylate and Benazepril Hydrochloride Capsules, Lupin, Ltd., Approval | Caduet (amlodipine besylate and atorvastatin calcium) Tablets, Pfizer, Inc., Labeling Revision | Amlodipine and Valsartan Tablets, Par Pharmaceutical, Inc., Tentative Approval | Exforge (amlodipine besylate and valsartan) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision | Lotrel (amlodipine besylate and benazapril hydrochloride) Capsules, Novartis Pharmaceuticals Corp., Labeling Revision | Amlodipine and Valsartan Tablets, Synthon Pharmaceuticals, Inc., Tentative Approval | Amlodipine Besylate Tablets, Vintage Pharmaceuticals, LLC, Approval | Amlodipine Besylate and Benazepril Hydrochloride Capsules, Mylan Pharmaceuticals Inc., Approval | Twynsta (telmisartan and amlodipine besylate) Tablets, Boehringer Ingelheim Pharmaceuticals, Inc., Labeling Revision | Tribenzor (olmesartan medoxomil, amlodipine and hydrochlorothiazide) Tablets, Daiichi Sankyo, Inc., Approval | Amlodipine Besylate and Benazepril Hydrochloride Capsules, Par Pharmaceutical, Inc., Approval | Tekamlo (aliskiren and amlodipine) Tablets, Novartis Pharmaceuticals Corp., Approval | Amlodipine Besylate and Benazepril Hydrochloride Capsules, Watson Laboratories, Inc., Approval | Lotrel (amlodipine besylate and benazapril hydrochloride) Capsules, Novartis, Labeling Revision | Amlodipine Besylate and Benazepril Hydrochloride Capsules, Dr. Reddy’s Laboratories Ltd., Tentative Approval | Amlodipine Besylate and Olmesartan Medoxomil Tablets, Matrix Laboratories Ltd., Tentative Approval | Tekamlo (aliskiren hemifumarate and amlodipine besylate) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision | Amlodipine Besylate Tablets, Hikma Pharmaceuticals, Approval | Amlodipine Besylate Tablets, Secan Pharmaceuticals, Inc., Approval | Norvasc (amlodipine besylate) Tablets, Pfizer Inc., Labeling Revision | Azor (amlodipine besylate and olmesartan medoxomil) Tablets, Daiichi Sankyo, Inc., Labeling Revision | Twynsta (amlodipine besylate and telmisartan) Tablets, Boehringer Ingelheim Pharmaceuticals, Inc., Labeling Revision | Tribenzor (olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide) Tablets, Daiichi Sankyo, Inc., Labeling Revision | Amlodipine Besylate and Benazepril Hydrochloride Capsules, TEVA Pharmaceuticals, Approval | Amlodipine Besylate and Benazepril Hydrochloride Capsules, Lupin Ltd., Approval | Amlodipine Besylate and Benazepril Hydrochloride Capsules, Mylan Pharmaceuticals, Inc., Approval | Amlodipine Besylate and Benazepril Hydrochloride Capsules, Watson Laboratories Inc., Approval | Amlodipine Besylate and Benazepril Hydrochloride Capsules, Dr. Reddy’s Laboratories Ltd., Approval | Amturnide (amlodipine besylate, aliskiren hemifumarate and hydrochlorothiazide) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision | Tekamlo, (aliskiren hemifumarate and amlodipine besylate) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision | Lotrel (amlodipine besylate and benazepril hydrochloride) Capsules, Novartis Pharmaceuticals Corp., Labeling Revision | Azor (amlodipine and olmesartan medoxomil) Tablets, Daiichi Sankyo, Inc., Labeling Revision | Norvasc (amlodipine besylate) Tablets, Pfizer Inc., Labeling Revision | Exforge (amlodipine and valsartan) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision | Exforge HCT (amlodipine, valsartan and hydrochlorothiazide) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision | Amturnide (aliskiren hemifumarate, amlodipine besylate and hydrochlorothiazide) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision | Tribenzor (olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide) Tablets, Daiichi Sankyo, Inc., Labeling Revision | Azor (amlodipine besylate and olmesartan medoxomil) Tablets, Daiichi Sankyo Inc., Labeling Revision | Twynsta (amlodipine besylate and telmisartan) Tablets, Boehringer Ingelheim Pharmaceuticals, Inc., Labeling Revision | Tekamlo (aliskiren hemifumarate and amlodipine besylate) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision | Exforge (amlodipine besylate and valsartan) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision | Exforge HCT (amlodipine besylate, valsartan and hydrochlorothiazide) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision | Lotrel, amlodipine besylate; benazepril hydrochloride, Capsule; Oral, Novartis, Labeling Revision | Tribenzor, amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil, Tablet; Oral, Daiichi Sankyo, Labeling Revision | Twynsta, amlodipine besylate; telmisartan, Tablet; Oral, Boehringer Ingelheim, Approval | Tekamlo, aliskiren hemifumarate; amlodipine besylate, Tablet; Oral, Novartis, Labeling Revision | Amturnide, aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide, Tablet; Oral, Novartis, Labeling Revision | Tekamlo, aliskiren hemifumarate; amlodipine besylate, Tablet; Oral, Novartis, Labeling Revision | Amturnide, aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide, Tablet; Oral, Novartis, Labeling Revision | Valturna, aliskiren hemifumarate; valsartan, Tablet; Oral, Novartis, Labeling Revision | Amturnide, aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide, Tablet; Oral, Novartis, Labeling Revision | Exforge Hct, amlodipine besylate; hydrochlorothiazide; valsartan, Tablet; Oral, Novartis, Labeling Revision | Twynsta, amlodipine besylate; telmisartan, Tablet; Oral, Boehringer Ingelheim, Labeling Revision | Amlodipine; Valsartan; Hydrochlorothiazide, amlodipine; valsartan; hydrochlorothiazide, Tablet; Oral, Teva Pharms, Tentative Approval | Tekturna, aliskiren hemifumarate, Tablet; Oral, Novartis, Labeling Revision | Tekamlo, aliskiren hemifumarate; amlodipine besylate, Tablet; Oral, Novartis, Labeling Revision | Amturnide, aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide, Tablet; Oral, Novartis, Labeling Revision | Amlodipine Besylate, amlodipine besylate, Tablet; Oral, Macleods Pharms Ltd, Approval | Caduet, amlodipine besylate; atorvastatin calcium, Tablet; Oral, Pfizer, Labeling Revision | Amlodipine Besylate; Benazepril Hydrochloride, amlodipine besylate; benazepril hydrochloride, Capsule; Oral, Aurobindo Pharma Ltd, Approval | Amlodipine,Valsartan and Hydrochlorothiazide, amlodipine; hydrochlorothiazide; valsartan, Tablet; Oral, Teva Pharms, Approval | Lotrel, amlodipine besylate; benazepril hydrochloride, Capsule; Oral, Novartis, Labeling Revision | Caduet, amlodipine besylate; atorvastatin calcium, Tablet; Oral, Pfizer, Labeling Revision | Twynsta, amlodipine besylate; telmisartan, Tablet; Oral, Boehringer Ingelheim, Labeling Revision | Norvasc, amlodipine besylate, Tablet; Oral, Pfizer, Manufacturing Change or Addition | Exforge Hct, amlodipine besylate; hydrochlorothiazide; valsartan, Tablet; Oral, Novartis, Labeling Revision | Exforge, amlodipine besylate; valsartan, Tablet; Oral, Novartis, Labeling Revision | Tribenzor, amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil, Tablet; Oral, Daiichi Sankyo, Labeling Revision | Azor, amlodipine besylate; olmesartan medoxomil, Tablet; Oral, Daiichi Sankyo, Labeling Revision | Azor, amlodipine besylate; olmesartan medoxomil, Tablet; Oral, Daiichi Sankyo, Labeling Revision | Norvasc, amlodipine besylate, Tablet; Oral, Pfizer, Labeling Revision | Tribenzor, amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil, Tablet; Oral, Daiichi Sankyo, Manufacturing Change or Addition | Azor, amlodipine besylate; olmesartan medoxomil, Tablet; Oral, Daiichi Sankyo, Manufacturing Change or Addition | Amlodipine Besylate; Benazepril Hydrochloride, amlodipine besylate; benazepril hydrochloride, Capsule; Oral, Zydus Pharms Usa Inc, Tentative Approval | Amlodipine Besylate and Valsartan, amlodipine besylate; valsartan, Tablet; Oral, Par Pharm Inc, Approval | Amlodipine Besylate and Valsartan, amlodipine besylate; valsartan, Tablet; Oral, Par Pharm Inc, Approval | Amlodipine; Valsartan, amlodipine; valsartan, Tablet; Oral, Par Pharm Inc, Approval | Amlodipine; Valsartan, amlodipine; valsartan, Tablet; Oral, Par Pharm Inc, Approval | Amlodipine; Valsartan; Hydrochlorothiazide, amlodipine; valsartan; hydrochlorothiazide, Tablet; Oral, Par Pharm Inc, Tentative Approval | Amlodipine Besylate, amlodipine besylate, Tablet; Oral, Accord Hlthcare, Approval | Amlodipine Besylate; Valsartan, amlodipine besylate; valsartan, Tablet; Oral, Lupin Ltd, Tentative Approval | Tribenzor, amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil, Tablet; Oral, Daiichi Sankyo, Manufacturing Change or Addition | Amlodipine; Valsartan; Hydrochlorothiazide, amlodipine; valsartan; hydrochlorothiazide, Tablet; Oral, Lupin Ltd, Tentative Approval
  
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