Application 091105
- Type
- ANDA
- Sponsor
- NOVAST LABS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ELINEST | ETHINYL ESTRADIOL; NORGESTREL | TABLET;ORAL-28 | 0.03MG;0.3MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 16714-365 | Elinest | Norgestrel and Ethinyl Estradiol | Northstar Rx LLC | ANDA | Current |