Application 075288
- Type
- ANDA
- Sponsor
- MAYNE PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LOW-OGESTREL-21 | ETHINYL ESTRADIOL; NORGESTREL | TABLET;ORAL-21 | 0.03MG;0.3MG | No | No |
| 002 | LOW-OGESTREL-28 | 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 |
|---|---|---|---|---|---|
| 51862-564 | Low-Ogestrel | Norgestrel and Ethinyl Estradiol | Mayne Pharma Inc. | ANDA | Current |
| 51862-564 | Low-Ogestrel | Norgestrel and Ethinyl Estradiol | Mayne Pharma Inc. | ANDA | Current |
| 51862-564 | Low-Ogestrel | Norgestrel and Ethinyl Estradiol | Mayne Pharma Inc. | ANDA | Current |
| 53002-1637 | Low-Ogestrel | Norgestrel and Ethinyl Estradiol | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1637 | Low-Ogestrel | Norgestrel and Ethinyl Estradiol | RPK Pharmaceuticals, Inc. | ANDA | Current |