Details for New Drug Application (NDA): 065378
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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-eight 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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