FdaApplication
NDA 017849
Identifiers
- fda_app_no: NDA017849
Properties
| Property | Value |
|---|---|
| applicant_name | ANI PHARMACEUTICALS INC |
| application_type | NDA |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| BRETHINE | TERBUTALINE SULFATE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| BRETHINE | TERBUTALINE SULFATE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
2 products