Application 022332
- Type
- NDA
- Sponsor
- ELI LILLY CO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ADCIRCA | TADALAFIL | TABLET;ORAL | 20MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 43353-070 | ADCIRCA | Tadalafil | Aphena Pharma Solutions - Tennessee, LLC | NDA | Current |
| 43353-070 | ADCIRCA | Tadalafil | Aphena Pharma Solutions - Tennessee, LLC | NDA | Current |
| 66302-467 | ADCIRCA | Tadalafil | United Therapeutics Corporation | NDA | Current |
| 66302-467 | ADCIRCA | Tadalafil | United Therapeutics Corporation | NDA | Current |
| 66302-467 | ADCIRCA | Tadalafil | United Therapeutics Corporation | NDA | Current |
| 66302-467 | ADCIRCA | Tadalafil | United Therapeutics Corporation | NDA | Current |
| 66302-467 | ADCIRCA | Tadalafil | United Therapeutics Corporation | NDA | Current |
| 66302-467 | ADCIRCA | Tadalafil | United Therapeutics Corporation | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 64629 | SUPPL | 2020-09-21 |
| 64580 | SUPPL | 2020-09-16 |
| 48333 | SUPPL | 2017-05-09 |
| 48305 | SUPPL | 2017-05-09 |
| 17253 | SUPPL | 2015-04-07 |
| 7249 | SUPPL | 2015-04-03 |
| 17252 | SUPPL | 2014-05-02 |
| 29608 | SUPPL | 2014-04-30 |
| 29607 | SUPPL | 2013-11-25 |
| 38589 | SUPPL | 2013-11-22 |
| 7248 | SUPPL | 2011-02-14 |
| 38588 | SUPPL | 2011-02-09 |
| 21996 | ORIG | 2009-08-03 |
| 7247 | ORIG | 2009-05-29 |
| 17251 | ORIG | 2009-05-25 |