Application 213034
- Type
- ANDA
- Sponsor
- HETERO LABS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DROSPIRENONE AND ETHINYL ESTRADIOL | DROSPIRENONE; ETHINYL ESTRADIOL | TABLET;ORAL-28 | 3MG;0.03MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 31722-945 | Drospirenone and Ethinyl Estradiol | Drospirenone and Ethinyl Estradiol | Camber Pharmaceuticals, Inc. | ANDA | Current |