Application 090716
- Type
- ANDA
- Sponsor
- NOVAST LABS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SETLAKIN | ETHINYL ESTRADIOL; LEVONORGESTREL | TABLET;ORAL | 0.03MG;0.15MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 16714-366 | SETLAKIN | Levonorgestrel and Ethinyl Estradiol | Northstar Rx LLC | ANDA | Current |