Details for New Drug Application (NDA): 021286
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NDA 021286 describes BENICAR, which is a drug marketed by Cosette and is included in two NDAs. It is available from one supplier. Additional details are available on the BENICAR profile page.
The generic ingredient in BENICAR is hydrochlorothiazide; olmesartan medoxomil. There are thirty-two drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; olmesartan medoxomil profile page.
The generic ingredient in BENICAR is hydrochlorothiazide; olmesartan medoxomil. There are thirty-two drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; olmesartan medoxomil profile page.
Summary for 021286
| Tradename: | BENICAR |
| Applicant: | Cosette |
| Ingredient: | olmesartan medoxomil |
| Patents: | 0 |
Pharmacology for NDA: 021286
| Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 021286
Suppliers and Packaging for NDA: 021286
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BENICAR | olmesartan medoxomil | TABLET;ORAL | 021286 | NDA | Cosette Pharmaceuticals, Inc. | 0713-0860 | 0713-0860-30 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0713-0860-30) |
| BENICAR | olmesartan medoxomil | TABLET;ORAL | 021286 | NDA | Cosette Pharmaceuticals, Inc. | 0713-0861 | 0713-0861-30 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0713-0861-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Apr 25, 2002 | TE: | AB | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
| Approval Date: | Apr 25, 2002 | TE: | AB | RLD: | Yes | ||||
Profile for product number 004
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
| Approval Date: | Apr 25, 2002 | TE: | AB | RLD: | Yes | ||||
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