Application 209031
- Type
- ANDA
- Sponsor
- GLENMARK PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HAILEY FE 1.5/30 | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | TABLET;ORAL-28 | 0.03MG;1.5MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 68462-503 | Hailey Fe 1.5/30 | Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-503 | Hailey 1.5/30 | Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-503 | Hailey Fe 1.5/30 | Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |