Application 207304
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | INCASSIA | NORETHINDRONE | TABLET;ORAL-28 | 0.35MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50102-200 | Tulana | NORETHINDRONE | Afaxys Pharma, LLC | ANDA | Current |
| 50102-200 | Tulana | NORETHINDRONE | Afaxys Pharma, LLC | ANDA | Current |
| 50102-200 | Tulana | NORETHINDRONE | Afaxys Pharma, LLC | ANDA | Current |
| 50102-200 | Tulana | NORETHINDRONE | Afaxys Pharma, LLC | ANDA | Current |
| 50102-300 | Lyleq | NORETHINDRONE | Afaxys Pharma, LLC | ANDA | Current |
| 50102-300 | Lyleq | NORETHINDRONE | Afaxys Pharma, LLC | ANDA | Current |
| 53002-1793 | Lyleq | NORETHINDRONE | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-2687 | Tulana | NORETHINDRONE | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 65862-925 | Incassia | NORETHINDRONE | Aurobindo Pharma Limited | ANDA | Current |
| 65862-925 | Incassia | NORETHINDRONE | Aurobindo Pharma Limited | ANDA | Current |
| 65862-925 | Incassia | NORETHINDRONE | Aurobindo Pharma Limited | ANDA | Current |
| 65862-925 | Incassia | NORETHINDRONE | Aurobindo Pharma Limited | ANDA | Current |
| 65862-925 | Incassia | NORETHINDRONE | Aurobindo Pharma Limited | ANDA | Current |
| 65862-925 | Incassia | NORETHINDRONE | Aurobindo Pharma Limited | ANDA | Current |
| 65862-925 | Incassia | NORETHINDRONE | Aurobindo Pharma Limited | ANDA | Current |