Application 201886
- Type
- ANDA
- Sponsor
- LUPIN LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VYFEMLA | ETHINYL ESTRADIOL; NORETHINDRONE | TABLET;ORAL-28 | 0.035MG;0.4MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 57297-875 | Vyfemla | norethindrone and ethinyl estradiol | LUPIN LIMITED | ANDA | Current |
| 68180-875 | Vyfemla | norethindrone and ethinyl estradiol | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-875 | Vyfemla | norethindrone and ethinyl estradiol | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-875 | Vyfemla | norethindrone and ethinyl estradiol | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-875 | Vyfemla | norethindrone and ethinyl estradiol | Lupin Pharmaceuticals, Inc. | ANDA | Current |