Details for New Drug Application (NDA): 021286
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The generic ingredient in BENICAR is hydrochlorothiazide; olmesartan medoxomil. There are thirty-two drug master file entries for this compound. Twelve 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 |
Expired US Patents for NDA 021286
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Cosette | BENICAR | olmesartan medoxomil | TABLET;ORAL | 021286-001 | Apr 25, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Cosette | BENICAR | olmesartan medoxomil | TABLET;ORAL | 021286-004 | Apr 25, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Cosette | BENICAR | olmesartan medoxomil | TABLET;ORAL | 021286-003 | Apr 25, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Cosette | BENICAR | olmesartan medoxomil | TABLET;ORAL | 021286-003 | Apr 25, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Cosette | BENICAR | olmesartan medoxomil | TABLET;ORAL | 021286-004 | Apr 25, 2002 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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