Application 019004
- Type
- NDA
- Sponsor
- ORTHO MCNEIL PHARM
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ORTHO-NOVUM 7/14-21 | ETHINYL ESTRADIOL; NORETHINDRONE | TABLET;ORAL-21 | 0.035MG,0.035MG;0.5MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
| 002 | ORTHO-NOVUM 7/14-28 | ETHINYL ESTRADIOL; NORETHINDRONE | TABLET;ORAL-28 | 0.035MG,0.035MG;0.5MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |