Application 090946
- Type
- ANDA
- Sponsor
- NOVAST LABS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DASETTA 7/7/7 | ETHINYL ESTRADIOL; NORETHINDRONE | TABLET;ORAL-28 | 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 16714-346 | Dasetta 7/7/7 | norethindrone and ethinyl estradiol | Northstar Rx LLC | ANDA | Current |