Application 203371
- Type
- ANDA
- Sponsor
- MYLAN LABS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | 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 |
|---|---|---|---|---|---|
| 0378-7308 | NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | norethindrone and ethinyl estradiol and ferrous fumarate | Mylan Pharmaceuticals Inc. | ANDA | Current |