Application 091204
- Type
- ANDA
- Sponsor
- NOVAST LABS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | WERA | ETHINYL ESTRADIOL; NORETHINDRONE | TABLET;ORAL-28 | 0.035MG;0.5MG | No | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 16714-370 | Wera | norethindrone and ethinyl estradiol | Northstar Rx LLC | ANDA | Current |
| 50090-1431 | Wera | Norethindrone and Ethinyl Estradiol | A-S Medication Solutions | ANDA | Current |
| 51862-892 | Necon | norethindrone and ethinyl estradiol | Mayne Pharma Inc. | ANDA | Current |