Details for New Drug Application (NDA): 210552
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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 210552
Tradename: | OLMESARTAN MEDOXOMIL |
Applicant: | Qilu |
Ingredient: | olmesartan medoxomil |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 210552
Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 210552
Suppliers and Packaging for NDA: 210552
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OLMESARTAN MEDOXOMIL | olmesartan medoxomil | TABLET;ORAL | 210552 | ANDA | Tris Pharma, Inc. | 27808-275 | 27808-275-01 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (27808-275-01) |
OLMESARTAN MEDOXOMIL | olmesartan medoxomil | TABLET;ORAL | 210552 | ANDA | Tris Pharma, Inc. | 27808-275 | 27808-275-02 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (27808-275-02) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Jan 10, 2019 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
Approval Date: | Jan 10, 2019 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
Approval Date: | Jan 10, 2019 | TE: | AB | RLD: | No |
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