Application 090947
- Type
- ANDA
- Sponsor
- NOVAST LABS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PHILITH | ETHINYL ESTRADIOL; NORETHINDRONE | TABLET;ORAL-28 | 0.035MG;0.4MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 16714-347 | Philith | Norethindrone and Ethinyl Estradiol Tablets | Northstar Rx LLC | ANDA | Current |