Application 202763
- Type
- NDA
- Sponsor
- ANI PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TESTOSTERONE | TESTOSTERONE | GEL;TRANSDERMAL | 25MG/2.5GM PACKET | No | No |
| 002 | TESTOSTERONE | TESTOSTERONE | GEL;TRANSDERMAL | 50MG/5GM PACKET | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 45748 | SUPPL | 2016-11-01 |
| 45679 | SUPPL | 2016-10-27 |
| 40212 | SUPPL | 2015-05-13 |
| 10103 | SUPPL | 2015-05-13 |
| 40210 | SUPPL | 2014-07-24 |
| 32297 | SUPPL | 2014-07-24 |
| 40211 | SUPPL | 2014-06-23 |
| 10102 | SUPPL | 2014-06-23 |
| 44864 | ORIG | 2012-04-17 |
| 43412 | ORIG | 2012-04-17 |
| 24104 | ORIG | 2012-03-06 |
| 43957 | ORIG | 2012-02-17 |
| 19373 | ORIG | 2012-02-17 |
| 10101 | ORIG | 2012-02-17 |