Details for New Drug Application (NDA): 020364
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The generic ingredient in LOTREL 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 020364
Tradename: | LOTREL |
Applicant: | Sandoz |
Ingredient: | amlodipine besylate; benazepril hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 020364
Mechanism of Action | Angiotensin-converting Enzyme Inhibitors Calcium Channel Antagonists Cytochrome P450 3A Inhibitors |
Physiological Effect | Decreased Blood Pressure |
Suppliers and Packaging for NDA: 020364
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LOTREL | amlodipine besylate; benazepril hydrochloride | CAPSULE;ORAL | 020364 | NDA | Novartis Pharmaceuticals Corporation | 0078-0364 | 0078-0364-05 | 100 CAPSULE in 1 BOTTLE (0078-0364-05) |
LOTREL | amlodipine besylate; benazepril hydrochloride | CAPSULE;ORAL | 020364 | NDA | Novartis Pharmaceuticals Corporation | 0078-0379 | 0078-0379-05 | 100 CAPSULE in 1 BOTTLE (0078-0379-05) |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 2.5MG BASE;10MG | ||||
Approval Date: | Mar 3, 1995 | TE: | AB | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 5MG BASE;10MG | ||||
Approval Date: | Mar 3, 1995 | TE: | AB | RLD: | Yes |
Profile for product number 004
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 5MG BASE;20MG | ||||
Approval Date: | Mar 3, 1995 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 020364
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 | ⤷ Sign Up | ⤷ Sign Up |
Sandoz | LOTREL | amlodipine besylate; benazepril hydrochloride | CAPSULE;ORAL | 020364-005 | Jun 20, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Sandoz | LOTREL | amlodipine besylate; benazepril hydrochloride | CAPSULE;ORAL | 020364-002 | Mar 3, 1995 | ⤷ Sign Up | ⤷ Sign Up |
Sandoz | LOTREL | amlodipine besylate; benazepril hydrochloride | CAPSULE;ORAL | 020364-003 | Mar 3, 1995 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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