Details for New Drug Application (NDA): 062059
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NDA 062059 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, Endo Operations, Hikma, 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-five 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-nine 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-nine suppliers are listed for this compound. Additional details are available on the amoxicillin; clavulanate potassium profile page.
Summary for 062059
| Tradename: | AMOXICILLIN |
| Applicant: | Chartwell Rx |
| Ingredient: | amoxicillin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 062059
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AMOXICILLIN | amoxicillin | FOR SUSPENSION;ORAL | 062059 | ANDA | Chartwell RX, LLC | 62135-776 | 62135-776-38 | 150 mL in 1 BOTTLE (62135-776-38) |
| AMOXICILLIN | amoxicillin | FOR SUSPENSION;ORAL | 062059 | ANDA | Chartwell RX, LLC | 62135-776 | 62135-776-42 | 100 mL in 1 BOTTLE (62135-776-42) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | FOR SUSPENSION;ORAL | Strength | 125MG/5ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | FOR SUSPENSION;ORAL | Strength | 250MG/5ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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