Application 005794
- Type
- NDA
- Sponsor
- ORTHO MCNEIL PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SULTRIN | TRIPLE SULFA (SULFABENZAMIDE;SULFACETAMIDE;SULFATHIAZOLE) | CREAM;VAGINAL | 3.7%;2.86%;3.42% | No | No |
| 002 | SULTRIN | TRIPLE SULFA (SULFABENZAMIDE;SULFACETAMIDE;SULFATHIAZOLE) | TABLET;VAGINAL | 184MG;143.75MG;172.5MG | No | No |