Application 012728
- Type
- NDA
- Sponsor
- ORTHO MCNEIL PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ORTHO-NOVUM 10-21 | MESTRANOL; NORETHINDRONE | TABLET;ORAL-21 | 0.06MG;10MG | No | No |
| 004 | ORTHO-NOVUM 1/50 21 | MESTRANOL; NORETHINDRONE | TABLET;ORAL-21 | 0.05MG;1MG | No | No |
| 005 | ORTHO-NOVUM 2-21 | MESTRANOL; NORETHINDRONE | TABLET;ORAL-21 | 0.1MG;2MG | No | No |