Application 201483
- Type
- ANDA
- Sponsor
- MYLAN LABS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NORETHINDRONE | NORETHINDRONE | TABLET;ORAL-28 | 0.35MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-7292 | NORETHINDRONE | norethindrone | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-7292 | NORETHINDRONE | norethindrone | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 76413-118 | Norethindrone | Norethindrone | Central Texas Community Health Centers | ANDA | Current |