Application 091453
- Type
- ANDA
- Sponsor
- NOVAST LABS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LARIN FE 1.5/30 | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | TABLET;ORAL-28 | 0.03MG;1.5MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 16714-405 | Larin Fe 1.5/30 | Norethindrone Acetate/Ethinyl Estradiol and Ferrous Fumarate | Northstar Rx LLC | ANDA | Current |
| 50090-2559 | Larin Fe 1.5/30 | Norethindrone Acetate/Ethinyl Estradiol and Ferrous Fumarate | A-S Medication Solutions | ANDA | Current |
| 51862-870 | Microgestin Fe 1.5/30 | Norethindrone Acetate/Ethinyl Estradiol and Ferrous Fumarate | Mayne Pharma Inc. | ANDA | Current |