Details for New Drug Application (NDA): 211049
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The generic ingredient in OLMESARTAN MEDOXOMIL is amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil. There are fifty drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil profile page.
Summary for 211049
Tradename: | OLMESARTAN MEDOXOMIL |
Applicant: | Sunshine |
Ingredient: | olmesartan medoxomil |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 211049
Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 211049
Suppliers and Packaging for NDA: 211049
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OLMESARTAN MEDOXOMIL | olmesartan medoxomil | TABLET;ORAL | 211049 | ANDA | Lannett Company, Inc. | 0527-2425 | 0527-2425-32 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0527-2425-32) |
OLMESARTAN MEDOXOMIL | olmesartan medoxomil | TABLET;ORAL | 211049 | ANDA | Lannett Company, Inc. | 0527-2425 | 0527-2425-46 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0527-2425-46) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Feb 22, 2019 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
Approval Date: | Feb 22, 2019 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
Approval Date: | Feb 22, 2019 | TE: | AB | RLD: | No |
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