Application 022504
- Type
- NDA
- Sponsor
- ELI LILLY AND CO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AXIRON | TESTOSTERONE | SOLUTION, METERED;TRANSDERMAL | 30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 48988 | SUPPL | 2017-07-14 |
| 48982 | SUPPL | 2017-07-14 |
| 48981 | SUPPL | 2017-07-14 |
| 47127 | SUPPL | 2017-02-07 |
| 47100 | SUPPL | 2017-02-06 |
| 46988 | SUPPL | 2017-01-27 |
| 45744 | SUPPL | 2016-11-01 |
| 45678 | SUPPL | 2016-10-27 |
| 29792 | SUPPL | 2015-05-13 |
| 17653 | SUPPL | 2015-05-13 |
| 42542 | SUPPL | 2014-07-07 |
| 38770 | SUPPL | 2014-06-23 |
| 7465 | SUPPL | 2014-06-23 |
| 29791 | SUPPL | 2011-12-28 |
| 17652 | SUPPL | 2011-12-23 |
| 44763 | ORIG | 2011-09-16 |
| 22038 | ORIG | 2011-09-16 |
| 44506 | ORIG | 2011-04-04 |
| 29790 | SUPPL | 2011-04-04 |
| 17651 | SUPPL | 2011-04-01 |
| 29789 | ORIG | 2010-11-29 |
| 38769 | ORIG | 2010-11-23 |