FdaApplication
NDA 007335
Identifiers
- fda_app_no: NDA007335
Properties
| Property | Value |
|---|---|
| applicant_name | APOTHECON INC DIV BRISTOL MYERS SQUIBB |
| application_type | NDA |
Products (5)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| PRONESTYL | PROCAINAMIDE HYDROCHLORIDE | 100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION |
| PRONESTYL | PROCAINAMIDE HYDROCHLORIDE | 375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL |
| PRONESTYL | PROCAINAMIDE HYDROCHLORIDE | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL |
| PRONESTYL | PROCAINAMIDE HYDROCHLORIDE | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL |
| PRONESTYL | PROCAINAMIDE HYDROCHLORIDE | 500MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION |
5 products