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Amlodipine besylate; benazepril hydrochlorideis the generic ingredient in two branded drugs marketed by Apotex, Aurobindo Pharma Ltd, Cipla, Dr Reddys Labs Inc, Lupin Pharms, Mylan, Strides Pharma, Teva Pharms, Watson Labs, Watson Labs Inc, and Sandoz, and is included in thirteen NDAs. Additional information is available in the individual branded drug profile pages.
Eighteen suppliers are listed for this compound. There is one tentative approval for this compound.
Recent Clinical Trials for amlodipine besylate; benazepril hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
|Shanghai Jiao Tong University School of Medicine||Phase 4|
|Novartis Pharmaceuticals||Phase 4|
|Dr. Reddy's Laboratories Limited||Phase 1|
Generic filers with tentative approvals for AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for amlodipine besylate; benazepril hydrochloride
|LOTREL||Capsules||amlodipine besylate; benazepril hydrochloride||5 mg/40 mg and 10 mg/40 mg||020364||1||2006-11-17|
|LOTREL||Capsules||amlodipine besylate; benazepril hydrochloride||2.5 mg/10 mg 5 mg/10 mg 5 mg/20 mg 10 mg/20 mg||020364||1||2004-06-09|
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||TE||Type||RLD||RS||Patent No.||Patent Expiration||Product||Substance||Delist Req.||Exclusivity Expiration|
|Sandoz||LOTREL||amlodipine besylate; benazepril hydrochloride||CAPSULE;ORAL||020364-002||Mar 3, 1995||AB||RX||Yes||No||⤷ Try a Trial||⤷ Try a Trial||⤷ Try a Trial|
|Lupin Pharms||AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE||amlodipine besylate; benazepril hydrochloride||CAPSULE;ORAL||078466-003||Feb 5, 2010||AB||RX||No||No||⤷ Try a Trial||⤷ Try a Trial||⤷ Try a Trial|
|Mylan||AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE||amlodipine besylate; benazepril hydrochloride||CAPSULE;ORAL||079047-002||Jul 5, 2011||DISCN||No||No||⤷ Try a Trial||⤷ Try a Trial||⤷ Try a Trial|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>TE||>Type||>RLD||>RS||>Patent No.||>Patent Expiration||>Product||>Substance||>Delist Req.||>Exclusivity Expiration|
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||Patent No.||Patent Expiration|
|Sandoz||LOTREL||amlodipine besylate; benazepril hydrochloride||CAPSULE;ORAL||020364-004||Mar 3, 1995||⤷ Try a Trial||⤷ Try a Trial|
|Sandoz||LOTREL||amlodipine besylate; benazepril hydrochloride||CAPSULE;ORAL||020364-005||Jun 20, 2002||⤷ Try a Trial||⤷ Try a Trial|
|Sandoz||LOTREL||amlodipine besylate; benazepril hydrochloride||CAPSULE;ORAL||020364-002||Mar 3, 1995||⤷ Try a Trial||⤷ Try a Trial|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>Patent No.||>Patent Expiration|
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