Application 209297
- Type
- ANDA
- Sponsor
- GLENMARK PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HAILEY 1.5/30 | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | TABLET;ORAL-21 | 0.03MG;1.5MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 68462-504 | Hailey 1.5/30 | Norethindrone Acetate and Ethinyl Estradiol | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-504 | Hailey 1.5/30 | Norethindrone Acetate and Ethinyl Estradiol | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |