Details for New Drug Application (NDA): 078466
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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 078466
Tradename: | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE |
Applicant: | Lupin Pharms |
Ingredient: | amlodipine besylate; benazepril hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 078466
Mechanism of Action | Angiotensin-converting Enzyme Inhibitors Calcium Channel Antagonists Cytochrome P450 3A Inhibitors |
Physiological Effect | Decreased Blood Pressure |
Suppliers and Packaging for NDA: 078466
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 | 078466 | ANDA | A-S Medication Solutions | 50090-5357 | 50090-5357-0 | 90 CAPSULE in 1 BOTTLE (50090-5357-0) |
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | amlodipine besylate; benazepril hydrochloride | CAPSULE;ORAL | 078466 | ANDA | A-S Medication Solutions | 50090-5389 | 50090-5389-0 | 90 CAPSULE in 1 BOTTLE (50090-5389-0) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 2.5MG BASE;10MG | ||||
Approval Date: | Feb 5, 2010 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 5MG BASE;10MG | ||||
Approval Date: | Feb 5, 2010 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 5MG BASE;20MG | ||||
Approval Date: | Feb 5, 2010 | TE: | AB | RLD: | No |
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