Application 078892
- Type
- ANDA
- Sponsor
- AMNEAL PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | ETHINYL ESTRADIOL; NORETHINDRONE | TABLET, CHEWABLE;ORAL | 0.035MG;0.4MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 65162-347 | Zenchent FE | Norethindrone and Ethinyl Estradiol | Amneal Pharmaceuticals of New York, LLC | ANDA | Current |
| 69238-1581 | Zenchent FE | Norethindrone and Ethinyl Estradiol | Amneal Pharmaceuticals NY LLC | ANDA | Current |