Details for New Drug Application (NDA): 065228
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NDA 065228 describes AMOXICILLIN, which is a drug marketed by Aurobindo, Chartwell, Hikma Pharms, Labs Atral, Micro Labs, Mylan, Sandoz, Strides Pharma, Sun Pharm Inds Ltd, Teva, Aurobindo Pharma Ltd, Chartwell Rx, Dava Pharms Inc, Hikma, Wockhardt Bio Ag, Apothecon, Aurobindo Pharma, 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-four 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-five 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-five suppliers are listed for this compound. Additional details are available on the amoxicillin; clavulanate potassium profile page.
Summary for 065228
| Tradename: | AMOXICILLIN |
| Applicant: | Sandoz |
| Ingredient: | amoxicillin |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 065228
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AMOXICILLIN | amoxicillin | TABLET;ORAL | 065228 | ANDA | Sandoz Inc | 0781-5061 | 0781-5061-01 | 100 TABLET, FILM COATED in 1 BOTTLE (0781-5061-01) |
| AMOXICILLIN | amoxicillin | TABLET;ORAL | 065228 | ANDA | Sandoz Inc | 0781-5061 | 0781-5061-20 | 20 TABLET, FILM COATED in 1 BOTTLE (0781-5061-20) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
| Approval Date: | Jul 13, 2005 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 875MG | ||||
| Approval Date: | Jul 13, 2005 | TE: | AB | RLD: | No | ||||
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