Details for New Drug Application (NDA): 217399
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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. Six suppliers are listed for this compound. Additional details are available on the amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil profile page.
Summary for 217399
Tradename: | OLMESARTAN MEDOXOMIL |
Applicant: | Msn |
Ingredient: | olmesartan medoxomil |
Patents: | 0 |
Pharmacology for NDA: 217399
Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 217399
Suppliers and Packaging for NDA: 217399
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OLMESARTAN MEDOXOMIL | olmesartan medoxomil | TABLET;ORAL | 217399 | ANDA | Novadoz Pharmaceuticals LLC | 72205-165 | 72205-165-30 | 30 TABLET, FILM COATED in 1 BOTTLE (72205-165-30) |
OLMESARTAN MEDOXOMIL | olmesartan medoxomil | TABLET;ORAL | 217399 | ANDA | Novadoz Pharmaceuticals LLC | 72205-165 | 72205-165-66 | 1000 TABLET, FILM COATED in 1 BOTTLE (72205-165-66) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Jan 18, 2023 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
Approval Date: | Jan 18, 2023 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
Approval Date: | Jan 18, 2023 | TE: | AB | RLD: | No |
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