Details for New Drug Application (NDA): 091431
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NDA 091431 describes AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, which is a drug marketed by Amneal, Aurobindo Pharma Ltd, Chartwell Rx, Dr Reddys Labs Inc, Heritage, Lupin Pharms, Pharmobedient, Rising, Teva Pharms, Watson Labs, and Watson Labs Inc, and is included in twelve NDAs. It is available from fifteen suppliers. Additional details are available on the AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE profile page.
The generic ingredient in AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE is amlodipine besylate; benazepril hydrochloride. There are fifty drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the amlodipine besylate; benazepril hydrochloride profile page.
The generic ingredient in AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE is amlodipine besylate; benazepril hydrochloride. There are fifty drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the amlodipine besylate; benazepril hydrochloride profile page.
Summary for 091431
| Tradename: | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE |
| Applicant: | Heritage |
| Ingredient: | amlodipine besylate; benazepril hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 091431
| Mechanism of Action | Angiotensin-converting Enzyme Inhibitors Calcium Channel Antagonists Cytochrome P450 3A Inhibitors |
| Physiological Effect | Decreased Blood Pressure |
Suppliers and Packaging for NDA: 091431
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | amlodipine besylate; benazepril hydrochloride | CAPSULE;ORAL | 091431 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-925 | 23155-925-01 | 100 CAPSULE in 1 BOTTLE (23155-925-01) |
| AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | amlodipine besylate; benazepril hydrochloride | CAPSULE;ORAL | 091431 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-925 | 23155-925-05 | 500 CAPSULE in 1 BOTTLE (23155-925-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 2.5MG BASE;10MG | ||||
| Approval Date: | Dec 30, 2013 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 5MG BASE;10MG | ||||
| Approval Date: | Dec 30, 2013 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 5MG BASE;20MG | ||||
| Approval Date: | Dec 30, 2013 | TE: | AB | RLD: | No | ||||
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