Application 022309
- Type
- NDA
- Sponsor
- ABBVIE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ANDROGEL | TESTOSTERONE | GEL, METERED;TRANSDERMAL | 1.62% (20.25MG/1.25GM ACTUATION) | Yes | Yes |
| 002 | ANDROGEL | TESTOSTERONE | GEL;TRANSDERMAL | 1.62% (20.25MG/1.25GM PACKET) | Yes | No |
| 003 | ANDROGEL | TESTOSTERONE | GEL;TRANSDERMAL | 1.62% (40.5MG/2.5GM PACKET) | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0051-8462 | Androgel | Testosterone | AbbVie Inc. | NDA | Current |
| 0051-8462 | Androgel | Testosterone | AbbVie Inc. | NDA | Current |
| 0051-8462 | Androgel | Testosterone | AbbVie Inc. | NDA | Current |
| 0051-8462 | Androgel | Testosterone | AbbVie Inc. | NDA | Current |
| 0051-8462 | Androgel | Testosterone | AbbVie Inc. | NDA | Current |
| 50090-1306 | Androgel | Testosterone | A-S Medication Solutions LLC | NDA | Current |
| 68382-362 | Testosterone | Testosterone | Zydus Pharmaceuticals USA Inc | NDA AUTHORIZED GENERIC | Current |
| 68382-362 | Testosterone | Testosterone | Zydus Pharmaceuticals USA Inc | NDA AUTHORIZED GENERIC | Current |
| 68382-362 | Testosterone | Testosterone | Zydus Pharmaceuticals USA Inc | NDA AUTHORIZED GENERIC | Current |
| 68382-362 | Testosterone | Testosterone | Zydus Pharmaceuticals USA Inc | NDA | Current |
| 68382-362 | Testosterone | Testosterone | Zydus Pharmaceuticals USA Inc | NDA AUTHORIZED GENERIC | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 82872 | SUPPL | 2025-07-15 |
| 82837 | SUPPL | 2025-07-14 |
| 82836 | SUPPL | 2025-07-14 |
| 58915 | SUPPL | 2019-06-03 |
| 58754 | SUPPL | 2019-05-16 |
| 58752 | SUPPL | 2019-05-16 |
| 58657 | SUPPL | 2019-05-13 |
| 57926 | SUPPL | 2019-03-07 |
| 57831 | SUPPL | 2019-02-28 |
| 45770 | APPL | 2016-11-02 |
| 45741 | SUPPL | 2016-11-01 |
| 45677 | SUPPL | 2016-10-27 |
| 38551 | SUPPL | 2015-05-13 |
| 29571 | SUPPL | 2015-05-13 |
| 17223 | SUPPL | 2014-11-20 |
| 7213 | SUPPL | 2014-11-18 |
| 38550 | SUPPL | 2014-06-23 |
| 7214 | SUPPL | 2014-06-23 |
| 21990 | SUPPL | 2014-01-16 |
| 29570 | SUPPL | 2013-05-22 |
| 17222 | SUPPL | 2013-05-20 |
| 29569 | SUPPL | 2013-03-15 |
| 38549 | SUPPL | 2012-09-11 |
| 29568 | SUPPL | 2012-09-10 |
| 44735 | ORIG | 2011-11-17 |
| 21989 | ORIG | 2011-11-17 |
| 7212 | ORIG | 2011-05-05 |
| 38548 | ORIG | 2011-04-29 |