Application 078834
- Type
- ANDA
- Sponsor
- MAYNE PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; LEVONORGESTREL | TABLET;ORAL | 0.03MG,0.01MG;0.15MG,N/A | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 51862-047 | Amethia | ETHINYL ESTRADIOL and LEVONORGESTREL | Mayne Pharma Inc | ANDA | Current |
| 51862-047 | Amethia | ETHINYL ESTRADIOL and LEVONORGESTREL | Mayne Pharma Inc | ANDA | Current |
| 51862-047 | Amethia | ETHINYL ESTRADIOL and LEVONORGESTREL | Mayne Pharma Inc | ANDA | Current |
| 51862-047 | Amethia | ETHINYL ESTRADIOL and LEVONORGESTREL | Mayne Pharma Inc | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 9190 | ORIG | 2011-06-02 |