Application 206286
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TADALAFIL | TADALAFIL | TABLET;ORAL | 20MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 65862-880 | Tadalafil | Tadalafil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-880 | Tadalafil | Tadalafil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-880 | Tadalafil | Tadalafil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-880 | Tadalafil | Tadalafil | Aurobindo Pharma Limited | ANDA | Current |
| 70518-2450 | Tadalafil | Tadalafil | REMEDYREPACK INC. | ANDA | Current |
| 70518-2450 | Tadalafil | Tadalafil | REMEDYREPACK INC. | ANDA | Current |
| 70518-2450 | Tadalafil | Tadalafil | REMEDYREPACK INC. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 54454 | ORIG | 2018-06-05 |
| 32789 | ORIG | 2015-10-20 |