Application 017489
- Type
- NDA
- Sponsor
- ORTHO MCNEIL PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 002 | ORTHO-NOVUM 1/35-21 | ETHINYL ESTRADIOL; NORETHINDRONE | TABLET;ORAL-21 | 0.035MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |