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BENAZEPRIL

 
 
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

Safety Information
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…

Benazepril Hydrochloride Tablets, 5, 10, 20 & 40 mg, Eon Labs, ANDA 76-402 2/26/03 | Benazepril Hydrochloride Tablets, 5, 10, 20 & 40 mg, Ranbaxy ANDA 76-344 2/26/03 | Benazepril Hydrochloride Tablets, 5, 10, 20 & 40 mg, Andrx ANDA 76-267 2/26/03 | Benazepril Hydrochloride & Hydrochlorothiazide Tablets, Andrx ANDA 76-342 Lotensin and Lotensin HCT(benazepril HCl) Tablets, Novartis Benazepril Hydrochloride Tablets, KV Pharmaceutical, Benazepril Hydrochloride Tablets, Teva Benazepril Hydrochloride Tablets, Mylan Pharmaceuticals, Benazepril Hydrochloride Tablets, Mylan Pharmaceuticals | Benazepril Hydrochloride Tablets, Ranbaxy | Benazepril Hydrochloride Tablets, Andrx Pharmaceuticals | Benazepril Hydrochloride Tablets, Ivax Pharmaceuticals | Benazepril Hydrochloride Tablets, Teva Pharmaceuticals | Benazepril Hydrochloride Tablets, KV Pharmaceutical | Benazepril Hydrochloride Tablets, Eon Labs, Inc. | Benazepril Hydrochloride & Hydrochlorothiazide Tablets, Mylan Pharmaceuticals | Benazepril Hydrochloride & Hydrochlorothiazide Tablets, Andrx Pharmaceuticals | Benazepril Hydrochloride & Hydrochlorothiazide Tablets, Eon Labs, Inc. | Benazepril Hydrochloride Tablets, Genpharm, Inc. | Benazepril Hydrochloride & Hydrochlorothiazide Tablets, Genpharm, Inc. Lotensin (benazepril HCl) Tablets, Novartis Pharmaceuticals Lotrel (amlodipine and benazepril HCl) Capsules, Novartis Pharmaceuticals Labeling Revision | Benazepril Hydrochloride & Hydrochlorothiazide Tablets, Ranbaxy, Approval | Benazepril Hydrochloride Tablets, BioKey, Inc., Approval | Benazepril Hydrochloride Tablets, Apotex, Approval | Amlodipine Maleate/Benazepril Hydrochloride Capsules, Dr. Reddy’s Labs, Tentative Approval | Lotensin (benazepril HCl) Tablets, Novartis Pharma, Labeling Revision | Lotensin HCT (benazepril HCl/hctz) Tablets, Novartis Pharma, Labeling Revision | Lotrel (amlodipine besylate and benazepril HCl) Capsules, Novartis Pharma, Labeling Revision | Amlodipine Besylate and Benazepril Hydrochloride Capsules, Teva Pharma, Approval | Lotrel (benazepril hydrochloride/amlodipine besylate) Capsules, Novartis Pharma, Control Supplement | Amlodipine Besylate and Benazepril Hydrochloride Capsules, Watson Labs, Tentative Approval | Amlodipine Besylate and Benazepril Hydrochloride Capsules, Kali Labs, Tentative Approval | Benazepril Hydrochloride Tablets, Aurobindo Pharma USA, Inc., Approval | Benazepril Hydrochloride Tablets, Zydus Pharmaceuticals USA, Inc., Approval | Lotensin (benazepril hydrochloride) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision | Lotensin HCT (benazepril hydrochloride and hydrochlorothiazide) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision | Amlodipine Besylate and Benazepril Hydrochloride Capsules, Mylan Pharmaceuticals Inc., Tentative Approval | Lotrel (amlodipine besylate and benazepril hydrochloride) Capsules, Novartis Pharmaceuticals Corporation, Labeling Revision | Lotensin (benazepril/hydrochlorothiazide) Tablets, Novartis, Labeling Revision | Lotensin HCT (benazepril/hydrochlorothiazide) Tablets, Novartis, Labeling Revision | Amlodipine besylate/Benazepril hydrochloride Capsules, Novartis Pharmaceuticals Corporation, Manufacturing Change or Addition | Amlodipine Besylate and Benazepril Hydrochloride Capsules, Cobalt Laboratories Inc., Tentative Approval | Amlodipine Besylate and Benazepril Hydrochloride Capsules, Lupin, Ltd., Approval | Lotrel (amlodipine besylate and benazapril hydrochloride) Capsules, Novartis Pharmaceuticals Corp., Labeling Revision | Amlodipine Besylate and Benazepril Hydrochloride Capsules, Mylan Pharmaceuticals Inc., Approval | Amlodipine Besylate and Benazepril Hydrochloride Capsules, Par Pharmaceutical, Inc., 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 | Lotensin HCT (benazapril hydrochloride and hydorchlorothiazide) Tablets, Novartis Pharmaceuticals, Labeling Revision | Lotensin (benazepril hydrochloride) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision | Lotensin HCT (benazepril hydrochloride and hydrochlorothiazide) Tablets, Novartis Pharmaceuticals Corp., 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 | Lotrel (amlodipine besylate and benazepril hydrochloride) Capsules, 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 | Lotensin, benazepril hydrochloride, Tablet; Oral, Novartis, Labeling Revision | Lotensin Hct, benazepril hydrochloride; hydrochlorothiazide, Tablet; Oral, Novartis, Labeling Revision | Lotensin Hct, benazepril hydrochloride; hydrochlorothiazide, Tablet; Oral, Novartis, Labeling Revision | Lotensin, benazepril hydrochloride, Tablet; Oral, Novartis, Labeling Revision | Lotensin Hct, benazepril hydrochloride; hydrochlorothiazide, Tablet; Oral, Novartis, Labeling Revision | Amlodipine Besylate; Benazepril Hydrochloride, amlodipine besylate; benazepril hydrochloride, Capsule; Oral, Aurobindo Pharma Ltd, Approval | Lotensin, benazepril hydrochloride, Tablet; Oral, Novartis, Labeling Revision | Lotensin Hct, benazepril hydrochloride; hydrochlorothiazide, Tablet; Oral, Novartis, Labeling Revision | Lotrel, amlodipine besylate; benazepril hydrochloride, Capsule; Oral, Novartis, Labeling Revision | Amlodipine Besylate; Benazepril Hydrochloride, amlodipine besylate; benazepril hydrochloride, Capsule; Oral, Zydus Pharms Usa Inc, Tentative Approval

^ FDA's latest approval appears at the bottom of this list. ^

                                                                   

 

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