Application 200630
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| 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 | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-6976 | Tadalafil | tadalafil | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-6976 | Tadalafil | tadalafil | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-6976 | Tadalafil | tadalafil | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-6976 | Tadalafil | tadalafil | Mylan Pharmaceuticals Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 55623 | ORIG | 2018-09-27 |