Application 209539
- Type
- ANDA
- Sponsor
- CIPLA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TADALAFIL | TADALAFIL | TABLET;ORAL | 2.5MG | No | No |
| 002 | TADALAFIL | TADALAFIL | TABLET;ORAL | 5MG | No | No |
| 003 | TADALAFIL | TADALAFIL | TABLET;ORAL | 10MG | No | No |
| 004 | TADALAFIL | TADALAFIL | TABLET;ORAL | 20MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50090-5187 | Tadalafil | Tadalafil | A-S Medication Solutions | ANDA | Current |
| 50090-5187 | Tadalafil | Tadalafil | A-S Medication Solutions | ANDA | Current |
| 69097-373 | Tadalafil | Tadalafil | Cipla USA Inc. | ANDA | Current |
| 69097-373 | Tadalafil | Tadalafil | Cipla USA Inc. | ANDA | Current |
| 69097-373 | Tadalafil | Tadalafil | Cipla USA Inc. | ANDA | Current |
| 69097-374 | Tadalafil | Tadalafil | Cipla USA Inc. | ANDA | Current |
| 69097-374 | Tadalafil | Tadalafil | Cipla USA Inc. | ANDA | Current |
| 69097-374 | Tadalafil | Tadalafil | Cipla USA Inc. | ANDA | Current |
| 69097-375 | Tadalafil | Tadalafil | Cipla USA Inc. | ANDA | Current |
| 69097-375 | Tadalafil | Tadalafil | Cipla USA Inc. | ANDA | Current |
| 69097-375 | Tadalafil | Tadalafil | Cipla USA Inc. | ANDA | Current |
| 69097-376 | Tadalafil | Tadalafil | Cipla USA Inc. | ANDA | Current |
| 69097-376 | Tadalafil | Tadalafil | Cipla USA Inc. | ANDA | Current |
| 69097-376 | Tadalafil | Tadalafil | Cipla USA Inc. | ANDA | Current |
| 70934-473 | Tadalafil | Tadalafil | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-473 | Tadalafil | Tadalafil | Denton Pharma, Inc. dba Northwind Pharmaceuticals | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 56492 | ORIG | 2018-11-16 |