Application 203448
- Type
- ANDA
- Sponsor
- LUPIN LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | KAITLIB FE | ETHINYL ESTRADIOL; NORETHINDRONE | TABLET, CHEWABLE;ORAL | 0.025MG;0.8MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 57297-903 | Kaitlib Fe | norethindrone and ethinyl estradiol | LUPIN LIMITED | ANDA | Current |
| 68180-903 | Kaitlib Fe | norethindrone and ethinyl estradiol | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-903 | Kaitlib Fe | norethindrone and ethinyl estradiol | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-903 | Kaitlib Fe | norethindrone and ethinyl estradiol | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-903 | Kaitlib Fe | norethindrone and ethinyl estradiol | Lupin Pharmaceuticals, Inc. | ANDA | Current |