FdaApplication
NDA 050597
Identifiers
- fda_app_no: NDA050597
Properties
| Property | Value |
|---|---|
| applicant_name | US ANTIBIOTICS LLC |
| application_type | NDA |
| approval_date | 1985-07-22 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| AUGMENTIN '125' | AMOXICILLIN; CLAVULANATE POTASSIUM | 125MG;EQ 31.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE;ORAL |
| AUGMENTIN '250' | AMOXICILLIN; CLAVULANATE POTASSIUM | 250MG;EQ 62.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE;ORAL |
2 products