Details for New Drug Application (NDA): 208130
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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 208130
Tradename: | OLMESARTAN MEDOXOMIL |
Applicant: | Sciegen Pharms Inc |
Ingredient: | olmesartan medoxomil |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 208130
Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 208130
Suppliers and Packaging for NDA: 208130
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OLMESARTAN MEDOXOMIL | olmesartan medoxomil | TABLET;ORAL | 208130 | ANDA | ScieGen Pharmaceuticals, Inc. | 50228-339 | 50228-339-10 | 1000 TABLET, FILM COATED in 1 BOTTLE (50228-339-10) |
OLMESARTAN MEDOXOMIL | olmesartan medoxomil | TABLET;ORAL | 208130 | ANDA | ScieGen Pharmaceuticals, Inc. | 50228-339 | 50228-339-30 | 30 TABLET, FILM COATED in 1 BOTTLE (50228-339-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Jun 29, 2018 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
Approval Date: | Jun 29, 2018 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
Approval Date: | Jun 29, 2018 | TE: | AB | RLD: | No |
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