FdaApplication
NDA 008303
Identifiers
- fda_app_no: NDA008303
Properties
| Property | Value |
|---|---|
| applicant_name | NOVARTIS PHARMACEUTICALS CORP |
| application_type | NDA |
Products (5)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| APRESOLINE | HYDRALAZINE HYDROCHLORIDE | 20MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION |
| APRESOLINE | HYDRALAZINE HYDROCHLORIDE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| APRESOLINE | HYDRALAZINE HYDROCHLORIDE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| APRESOLINE | HYDRALAZINE HYDROCHLORIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| APRESOLINE | HYDRALAZINE HYDROCHLORIDE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
5 products