Application 205762
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TRI-LO-MILI | ETHINYL ESTRADIOL; NORGESTIMATE | TABLET;ORAL-28 | 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50102-231 | Tri-VyLibra Lo | Norgestimate and Ethinyl Estradiol | Afaxys Pharma, LLC | ANDA | Current |
| 50102-231 | Tri-VyLibra Lo | Norgestimate and Ethinyl Estradiol | Afaxys Pharma, LLC | ANDA | Current |
| 50102-231 | Tri-VyLibra Lo | Norgestimate and Ethinyl Estradiol | Afaxys Pharma, LLC | ANDA | Current |
| 50102-231 | Tri-VyLibra Lo | Norgestimate and Ethinyl Estradiol | Afaxys Pharma, LLC | ANDA | Current |
| 50102-231 | Tri-VyLibra Lo | Norgestimate and Ethinyl Estradiol | Afaxys Pharma, LLC | ANDA | Current |
| 53002-1778 | Tri-VyLibra Lo | Norgestimate and Ethinyl Estradiol | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 65862-778 | Tri-Lo-Mili | Norgestimate and Ethinyl Estradiol | Aurobindo Pharma Limited | ANDA | Current |
| 65862-778 | Tri-Lo-Mili | Norgestimate and Ethinyl Estradiol | Aurobindo Pharma Limited | ANDA | Current |
| 65862-778 | Tri-Lo-Mili | Norgestimate and Ethinyl Estradiol | Aurobindo Pharma Limited | ANDA | Current |
| 65862-778 | Tri-Lo-Mili | Norgestimate and Ethinyl Estradiol | Aurobindo Pharma Limited | ANDA | Current |
| 65862-778 | Tri-Lo-Mili | Norgestimate and Ethinyl Estradiol | Aurobindo Pharma Limited | ANDA | Current |
| 65862-778 | Tri-Lo-Mili | Norgestimate and Ethinyl Estradiol | Aurobindo Pharma Limited | ANDA | Current |
| 65862-778 | Tri-Lo-Mili | Norgestimate and Ethinyl Estradiol | Aurobindo Pharma Limited | ANDA | Current |
| 65862-778 | Tri-Lo-Mili | Norgestimate and Ethinyl Estradiol | Aurobindo Pharma Limited | ANDA | Current |