Details for New Drug Application (NDA): 065189
NDA 065189 describes AMOXICILLIN AND CLAVULANATE POTASSIUM, which is a drug marketed by Aurobindo Pharma, Aurobindo Pharma Ltd, Chartwell Rx, Cipla, Deva Holding As, Hikma Pharms, Micro Labs, Micro Labs Ltd India, Sandoz, Sandoz Inc, Sun Pharm Inds Ltd, Apotex Inc, and Regcon Holdings, and is included in forty-one NDAs. It is available from thirty-one suppliers. Additional details are available on the AMOXICILLIN AND CLAVULANATE POTASSIUM profile page.
The generic ingredient in AMOXICILLIN AND CLAVULANATE POTASSIUM is amoxicillin; clavulanate potassium. There is one drug master file entry for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the amoxicillin; clavulanate potassium profile page.
The generic ingredient in AMOXICILLIN AND CLAVULANATE POTASSIUM is amoxicillin; clavulanate potassium. There is one drug master file entry for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the amoxicillin; clavulanate potassium profile page.
Summary for 065189
| Tradename: | AMOXICILLIN AND CLAVULANATE POTASSIUM |
| Applicant: | Sandoz |
| Ingredient: | amoxicillin; clavulanate potassium |
| Patents: | 0 |
Pharmacology for NDA: 065189
| Mechanism of Action | beta Lactamase Inhibitors |
Suppliers and Packaging for NDA: 065189
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AMOXICILLIN AND CLAVULANATE POTASSIUM | amoxicillin; clavulanate potassium | TABLET;ORAL | 065189 | ANDA | Sandoz Inc | 0781-1874 | 0781-1874-31 | 30 TABLET, FILM COATED in 1 BOTTLE (0781-1874-31) |
| AMOXICILLIN AND CLAVULANATE POTASSIUM | amoxicillin; clavulanate potassium | TABLET;ORAL | 065189 | ANDA | Asclemed USA, Inc. | 76420-503 | 76420-503-30 | 30 TABLET, FILM COATED in 1 BOTTLE (76420-503-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG;EQ 125MG BASE | ||||
| Approval Date: | Aug 23, 2005 | TE: | AB | RLD: | No | ||||
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