Details for New Drug Application (NDA): 209010
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The generic ingredient in AMLODIPINE AND OLMESARTAN MEDOXOMIL is amlodipine besylate; olmesartan medoxomil. 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; olmesartan medoxomil profile page.
Summary for 209010
Tradename: | AMLODIPINE AND OLMESARTAN MEDOXOMIL |
Applicant: | Sciegen Pharms Inc |
Ingredient: | amlodipine besylate; olmesartan medoxomil |
Patents: | 0 |
Pharmacology for NDA: 209010
Mechanism of Action | Angiotensin 2 Receptor Antagonists Calcium Channel Antagonists |
Suppliers and Packaging for NDA: 209010
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMLODIPINE AND OLMESARTAN MEDOXOMIL | amlodipine besylate; olmesartan medoxomil | TABLET;ORAL | 209010 | ANDA | ScieGen Pharmaceuticals, Inc | 50228-365 | 50228-365-10 | 1000 TABLET, FILM COATED in 1 BOTTLE (50228-365-10) |
AMLODIPINE AND OLMESARTAN MEDOXOMIL | amlodipine besylate; olmesartan medoxomil | TABLET;ORAL | 209010 | ANDA | ScieGen Pharmaceuticals, Inc | 50228-365 | 50228-365-30 | 30 TABLET, FILM COATED in 1 BOTTLE (50228-365-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE;20MG | ||||
Approval Date: | Dec 3, 2018 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE;40MG | ||||
Approval Date: | Dec 3, 2018 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE;20MG | ||||
Approval Date: | Dec 3, 2018 | TE: | AB | RLD: | No |
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