Application 206287
- Type
- ANDA
- Sponsor
- LUPIN ATLANTIS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MIBELAS 24 FE | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | TABLET, CHEWABLE;ORAL | 0.02MG;1MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 68180-911 | Mibelas 24 Fe | NORETHINDRONE ACETATE, ETHINYL ESTRADIOL AND FERROUS FUMARATE | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-911 | Mibelas 24 Fe | NORETHINDRONE ACETATE, ETHINYL ESTRADIOL AND FERROUS FUMARATE | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-911 | Mibelas 24 Fe | NORETHINDRONE ACETATE, ETHINYL ESTRADIOL AND FERROUS FUMARATE | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-911 | Mibelas 24 Fe | NORETHINDRONE ACETATE, ETHINYL ESTRADIOL AND FERROUS FUMARATE | Lupin Pharmaceuticals, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 32790 | ORIG | 2016-05-26 |