Application 016936
- Type
- NDA
- Sponsor
- GD SEARLE LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DEMULEN 1/50-28 | ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE | TABLET;ORAL-28 | 0.05MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |