Details for New Drug Application (NDA): 207771
✉ Email this page to a colleague
The generic ingredient in AMLODIPINE AND OLMESARTAN MEDOXOMIL is amlodipine besylate; olmesartan medoxomil. There are fifty drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the amlodipine besylate; olmesartan medoxomil profile page.
Summary for 207771
Tradename: | AMLODIPINE AND OLMESARTAN MEDOXOMIL |
Applicant: | Zydus Pharms |
Ingredient: | amlodipine besylate; olmesartan medoxomil |
Patents: | 0 |
Suppliers and Packaging for NDA: 207771
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMLODIPINE AND OLMESARTAN MEDOXOMIL | amlodipine besylate; olmesartan medoxomil | TABLET;ORAL | 207771 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-927 | 68382-927-01 | 100 TABLET, FILM COATED in 1 BOTTLE (68382-927-01) |
AMLODIPINE AND OLMESARTAN MEDOXOMIL | amlodipine besylate; olmesartan medoxomil | TABLET;ORAL | 207771 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-927 | 68382-927-05 | 500 TABLET, FILM COATED in 1 BOTTLE (68382-927-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE;20MG | ||||
Approval Date: | Sep 22, 2017 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE;40MG | ||||
Approval Date: | Sep 22, 2017 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE;20MG | ||||
Approval Date: | Sep 22, 2017 | TE: | AB | RLD: | No |
Complete Access Available with Subscription