Details for New Drug Application (NDA): 208659
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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 208659
Tradename: | OLMESARTAN MEDOXOMIL |
Applicant: | Inventia |
Ingredient: | olmesartan medoxomil |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 208659
Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 208659
Suppliers and Packaging for NDA: 208659
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OLMESARTAN MEDOXOMIL | olmesartan medoxomil | TABLET;ORAL | 208659 | ANDA | Inventia Healthcare Limited | 49252-065 | 49252-065-10 | 30 TABLET, COATED in 1 BOTTLE (49252-065-10) |
OLMESARTAN MEDOXOMIL | olmesartan medoxomil | TABLET;ORAL | 208659 | ANDA | Inventia Healthcare Limited | 49252-065 | 49252-065-12 | 90 TABLET, COATED in 1 BOTTLE (49252-065-12) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | May 18, 2020 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
Approval Date: | May 18, 2020 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
Approval Date: | May 18, 2020 | TE: | RLD: | No |
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