Details for New Drug Application (NDA): 065119
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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 065119
Tradename: | AMOXICILLIN |
Applicant: | Teva |
Ingredient: | amoxicillin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 065119
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMOXICILLIN | amoxicillin | FOR SUSPENSION;ORAL | 065119 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-4160 | 0093-4160-73 | 100 mL in 1 BOTTLE (0093-4160-73) |
AMOXICILLIN | amoxicillin | FOR SUSPENSION;ORAL | 065119 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-4160 | 0093-4160-76 | 50 mL in 1 BOTTLE (0093-4160-76) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 200MG/5ML | ||||
Approval Date: | Dec 4, 2002 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 400MG/5ML | ||||
Approval Date: | Dec 4, 2002 | TE: | AB | RLD: | No |
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