Details for New Drug Application (NDA): 202239
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The generic ingredient in AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE is amlodipine besylate; benazepril hydrochloride. There are fifty drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the amlodipine besylate; benazepril hydrochloride profile page.
Summary for 202239
Tradename: | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE |
Applicant: | Aurobindo Pharma Ltd |
Ingredient: | amlodipine besylate; benazepril hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 202239
Mechanism of Action | Angiotensin-converting Enzyme Inhibitors Calcium Channel Antagonists Cytochrome P450 3A Inhibitors |
Physiological Effect | Decreased Blood Pressure |
Suppliers and Packaging for NDA: 202239
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 | 202239 | ANDA | AvKARE | 42291-011 | 42291-011-01 | 100 CAPSULE in 1 BOTTLE (42291-011-01) |
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | amlodipine besylate; benazepril hydrochloride | CAPSULE;ORAL | 202239 | ANDA | AvKARE | 42291-012 | 42291-012-01 | 100 CAPSULE in 1 BOTTLE (42291-012-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 2.5MG BASE;10MG | ||||
Approval Date: | Sep 5, 2012 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 5MG BASE;10MG | ||||
Approval Date: | Sep 5, 2012 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 5MG BASE;20MG | ||||
Approval Date: | Sep 5, 2012 | TE: | AB | RLD: | No |
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