Details for New Drug Application (NDA): 050575
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The generic ingredient in AUGMENTIN '250' 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 050575
Tradename: | AUGMENTIN '250' |
Applicant: | Us Antibiotics |
Ingredient: | amoxicillin; clavulanate potassium |
Patents: | 0 |
Pharmacology for NDA: 050575
Mechanism of Action | beta Lactamase Inhibitors |
Suppliers and Packaging for NDA: 050575
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AUGMENTIN '125' | amoxicillin; clavulanate potassium | FOR SUSPENSION;ORAL | 050575 | NDA | Allegis Pharmaceuticals, LLC | 28595-240 | 28595-240-35 | 100 mL in 1 BOTTLE (28595-240-35) |
AUGMENTIN '125' | amoxicillin; clavulanate potassium | FOR SUSPENSION;ORAL | 050575 | NDA | Allegis Pharmaceuticals, LLC | 28595-240 | 28595-240-36 | 150 mL in 1 BOTTLE (28595-240-36) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 125MG/5ML;EQ 31.25MG BASE/5ML | ||||
Approval Date: | Aug 6, 1984 | TE: | AB | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 250MG/5ML;EQ 62.5MG BASE/5ML | ||||
Approval Date: | Aug 6, 1984 | TE: | AB | RLD: | Yes |
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