Details for New Drug Application (NDA): 065191
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NDA 065191 describes AMOXICILLIN AND CLAVULANATE POTASSIUM, which is a drug marketed by Aurobindo Pharma, Aurobindo Pharma Ltd, Cipla, Deva Holding As, Hikma Pharms, Micro Labs, Micro Labs Ltd India, Sandoz, Sandoz Inc, Sun Pharm Inds Ltd, Teva, Chartwell Rx, Apotex Inc, and Teva Pharms Usa, and is included in forty-one NDAs. It is available from thirty-three 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 are forty-six drug master file entries for this compound. Thirty-seven 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 are forty-six drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the amoxicillin; clavulanate potassium profile page.
Summary for 065191
| Tradename: | AMOXICILLIN AND CLAVULANATE POTASSIUM |
| Applicant: | Hikma Pharms |
| Ingredient: | amoxicillin; clavulanate potassium |
| Patents: | 0 |
Pharmacology for NDA: 065191
| Mechanism of Action | beta Lactamase Inhibitors |
Suppliers and Packaging for NDA: 065191
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AMOXICILLIN AND CLAVULANATE POTASSIUM | amoxicillin; clavulanate potassium | FOR SUSPENSION;ORAL | 065191 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9981 | 0143-9981-01 | 100 mL in 1 BOTTLE (0143-9981-01) |
| AMOXICILLIN AND CLAVULANATE POTASSIUM | amoxicillin; clavulanate potassium | FOR SUSPENSION;ORAL | 065191 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9981 | 0143-9981-50 | 50 mL in 1 BOTTLE (0143-9981-50) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 400MG/5ML;EQ 57MG BASE/5ML | ||||
| Approval Date: | Jan 25, 2005 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 200MG/5ML;EQ 28.5MG BASE/5ML | ||||
| Approval Date: | Jan 25, 2005 | TE: | AB | RLD: | No | ||||
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