Details for New Drug Application (NDA): 065117
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The generic ingredient in AMOXICILLIN AND CLAVULANATE POTASSIUM 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 065117
Tradename: | AMOXICILLIN AND CLAVULANATE POTASSIUM |
Applicant: | Sandoz Inc |
Ingredient: | amoxicillin; clavulanate potassium |
Patents: | 0 |
Pharmacology for NDA: 065117
Mechanism of Action | beta Lactamase Inhibitors |
Suppliers and Packaging for NDA: 065117
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMOXICILLIN AND CLAVULANATE POTASSIUM | amoxicillin; clavulanate potassium | TABLET;ORAL | 065117 | ANDA | medsource pharmaceuticals | 45865-870 | 45865-870-20 | 20 TABLET, FILM COATED in 1 BOTTLE (45865-870-20) |
AMOXICILLIN AND CLAVULANATE POTASSIUM | amoxicillin; clavulanate potassium | TABLET;ORAL | 065117 | ANDA | RPK Pharmaceuticals, Inc. | 53002-2391 | 53002-2391-1 | 20 TABLET, FILM COATED in 1 BOTTLE (53002-2391-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG;EQ 125MG BASE | ||||
Approval Date: | Nov 27, 2002 | TE: | AB | RLD: | No |
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