Application 205449
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | MILI | ETHINYL ESTRADIOL; NORGESTIMATE | TABLET;ORAL-28 | 0.035MG;0.25MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50090-3962 | Mili | norgestimate and ethinyl estradiol | A-S Medication Solutions | ANDA | Current |
| 50102-235 | VyLibra | norgestimate and ethinyl estradiol | Afaxys Pharma, LLC | ANDA | Current |
| 50102-235 | VyLibra | norgestimate and ethinyl estradiol | Afaxys Pharma, LLC | ANDA | Current |
| 50102-235 | VyLibra | norgestimate and ethinyl estradiol | Afaxys Pharma, LLC | ANDA | Current |
| 50102-235 | VyLibra | norgestimate and ethinyl estradiol | Afaxys Pharma, LLC | ANDA | Current |
| 50102-235 | VyLibra | norgestimate and ethinyl estradiol | Afaxys Pharma, LLC | ANDA | Current |
| 53002-1777 | VyLibra | norgestimate and ethinyl estradiol | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 65862-776 | Mili | norgestimate and ethinyl estradiol | Aurobindo Pharma Limited | ANDA | Current |
| 65862-776 | Mili | norgestimate and ethinyl estradiol | Aurobindo Pharma Limited | ANDA | Current |
| 65862-776 | Mili | norgestimate and ethinyl estradiol | Aurobindo Pharma Limited | ANDA | Current |
| 65862-776 | Mili | norgestimate and ethinyl estradiol | Aurobindo Pharma Limited | ANDA | Current |
| 65862-776 | Mili | norgestimate and ethinyl estradiol | Aurobindo Pharma Limited | ANDA | Current |
| 65862-776 | Mili | norgestimate and ethinyl estradiol | Aurobindo Pharma Limited | ANDA | Current |
| 65862-776 | Mili | norgestimate and ethinyl estradiol | Aurobindo Pharma Limited | ANDA | Current |
| 65862-776 | Mili | norgestimate and ethinyl estradiol | Aurobindo Pharma Limited | ANDA | Current |