Application 206053
- Type
- ANDA
- Sponsor
- MYLAN LABS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; LEVONORGESTREL | TABLET;ORAL | 0.02MG,0.15MG; 0.025MG,0.15MG;0.03MG,0.15MG; 0.01MG,N/A | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-7316 | LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | levonorgestrel and ethinyl estradiol and ethinyl estradiol | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-7316 | LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | levonorgestrel and ethinyl estradiol and ethinyl estradiol | Mylan Pharmaceuticals Inc. | ANDA | Current |