Details for New Drug Application (NDA): 065378
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NDA 065378 describes AMOXICILLIN, which is a drug marketed by Aurobindo, Chartwell, Hikma Pharms, Labs Atral, Micro Labs, Mylan, Sandoz, Strides Pharma Intl, Sun Pharm Inds Ltd, Teva, Aurobindo Pharma Ltd, Chartwell Rx, Hikma, Ph Health, Apothecon, Aurobindo Pharma, Cipla, Deva Holding As, Micro Labs Ltd India, Sandoz Inc, Apotex Inc, and Teva Pharms Usa, and is included in eighty-five NDAs. It is available from thirty-seven suppliers. Additional details are available on the AMOXICILLIN profile page.
The generic ingredient in AMOXICILLIN 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 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 065378
| Tradename: | AMOXICILLIN |
| Applicant: | Sandoz |
| Ingredient: | amoxicillin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 065378
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AMOXICILLIN | amoxicillin | FOR SUSPENSION;ORAL | 065378 | ANDA | Sandoz Inc | 0781-6156 | 0781-6156-46 | 100 mL in 1 BOTTLE (0781-6156-46) |
| AMOXICILLIN | amoxicillin | FOR SUSPENSION;ORAL | 065378 | ANDA | Sandoz Inc | 0781-6156 | 0781-6156-52 | 50 mL in 1 BOTTLE (0781-6156-52) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 200MG/5ML | ||||
| Approval Date: | Mar 26, 2007 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 400MG/5ML | ||||
| Approval Date: | Mar 26, 2007 | TE: | AB | RLD: | No | ||||
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