Details for New Drug Application (NDA): 065228
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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-nine 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 |
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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