Details for New Drug Application (NDA): 050564
✉ Email this page to a colleague
NDA 050564 describes AUGMENTIN '500', which is a drug marketed by Us Antibiotics and is included in one NDA. Additional details are available on the AUGMENTIN '500' profile page.
The generic ingredient in AUGMENTIN '500' 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.
The generic ingredient in AUGMENTIN '500' 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 050564
| Tradename: | AUGMENTIN '500' |
| Applicant: | Us Antibiotics |
| Ingredient: | amoxicillin; clavulanate potassium |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 250MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Aug 6, 1984 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 500MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Aug 6, 1984 | TE: | RLD: | Yes | |||||
Complete Access Available with Subscription
