Details for New Drug Application (NDA): 050597
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NDA 050597 describes AUGMENTIN '250', which is a drug marketed by Us Antibiotics and is included in three NDAs. It is available from three suppliers. Additional details are available on the AUGMENTIN '250' profile page.
The generic ingredient in AUGMENTIN '250' 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.
The generic ingredient in AUGMENTIN '250' 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 050597
| Tradename: | AUGMENTIN '250' |
| Applicant: | Us Antibiotics |
| Ingredient: | amoxicillin; clavulanate potassium |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, CHEWABLE;ORAL | Strength | 125MG;EQ 31.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Jul 22, 1985 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, CHEWABLE;ORAL | Strength | 250MG;EQ 62.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Jul 22, 1985 | TE: | RLD: | Yes | |||||
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