FdaApplication
ANDA 075385
Identifiers
- fda_app_no: ANDA075385
Properties
| Property | Value |
|---|---|
| applicant_name | IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA |
| application_type | ANDA |
| approval_date | 2002-03-01 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
3 products