Details for New Drug Application (NDA): 061931
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NDA 061931 describes AMOXICILLIN PEDIATRIC, which is a drug marketed by Teva and is included in one NDA. It is available from five suppliers. Additional details are available on the AMOXICILLIN PEDIATRIC profile page.
The generic ingredient in AMOXICILLIN PEDIATRIC is amoxicillin. There are forty-six drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the amoxicillin profile page.
The generic ingredient in AMOXICILLIN PEDIATRIC is amoxicillin. There are forty-six drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the amoxicillin profile page.
Summary for 061931
| Tradename: | AMOXICILLIN PEDIATRIC |
| Applicant: | Teva |
| Ingredient: | amoxicillin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 061931
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AMOXICILLIN | amoxicillin | FOR SUSPENSION;ORAL | 061931 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-4155 | 0093-4155-73 | 100 mL in 1 BOTTLE (0093-4155-73) |
| AMOXICILLIN | amoxicillin | FOR SUSPENSION;ORAL | 061931 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-4155 | 0093-4155-79 | 80 mL in 1 BOTTLE (0093-4155-79) |
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: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 250MG/5ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 50MG/ML | ||||
| Approval Date: | Dec 1, 1982 | TE: | AB | RLD: | No | ||||
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