Application 013294
- Type
- NDA
- Sponsor
- ROCHE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AZO GANTANOL | PHENAZOPYRIDINE HYDROCHLORIDE; SULFAMETHOXAZOLE | TABLET;ORAL | 100MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |