Application 016954
- Type
- NDA
- Sponsor
- JANSSEN PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MICRONOR | NORETHINDRONE | TABLET;ORAL-28 | 0.35MG | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50458-194 | Ortho Micronor | NORETHINDRONE | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-194 | Ortho Micronor | NORETHINDRONE | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-194 | Ortho Micronor | NORETHINDRONE | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-194 | Ortho Micronor | NORETHINDRONE | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-194 | Ortho Micronor | NORETHINDRONE | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 52544-892 | Jolivette | NORETHINDRONE | Actavis Pharma, Inc. | NDA | Current |