Application 021015
- Type
- NDA
- Sponsor
- ABBVIE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ANDROGEL | TESTOSTERONE | GEL;TRANSDERMAL | 25MG/2.5GM PACKET | Yes | No |
| 002 | ANDROGEL | TESTOSTERONE | GEL;TRANSDERMAL | 50MG/5GM PACKET | Yes | Yes |
| 003 | ANDROGEL | TESTOSTERONE | GEL, METERED;TRANSDERMAL | 12.5MG/1.25GM ACTUATION | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0051-8425 | Androgel | Testosterone | AbbVie Inc. | NDA | Current |
| 0051-8425 | Androgel | Testosterone | AbbVie Inc. | NDA | Current |
| 0051-8425 | Androgel | Testosterone | AbbVie Inc. | NDA | Current |
| 0051-8425 | Androgel | Testosterone | AbbVie Inc. | NDA | Current |
| 0051-8425 | Androgel | Testosterone | AbbVie Inc. | NDA | Current |
| 0051-8450 | Androgel | Testosterone | AbbVie Inc. | NDA | Current |
| 0051-8450 | Androgel | Testosterone | AbbVie Inc. | NDA | Current |
| 0051-8450 | Androgel | Testosterone | AbbVie Inc. | NDA | Current |
| 0051-8450 | Androgel | Testosterone | AbbVie Inc. | NDA | Current |
| 0051-8450 | Androgel | Testosterone | AbbVie Inc. | NDA | Current |
| 21695-112 | Androgel | testosterone | Rebel Distributors Corp. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 82868 | SUPPL | 2025-07-15 |
| 82835 | SUPPL | 2025-07-14 |
| 82834 | SUPPL | 2025-07-14 |
| 58912 | SUPPL | 2019-06-03 |
| 58756 | SUPPL | 2019-05-16 |
| 58755 | SUPPL | 2019-05-16 |
| 58680 | SUPPL | 2019-05-14 |
| 57942 | SUPPL | 2019-03-08 |
| 57829 | SUPPL | 2019-02-28 |
| 45740 | SUPPL | 2016-11-01 |
| 45672 | SUPPL | 2016-10-27 |
| 26498 | SUPPL | 2015-05-13 |
| 14174 | SUPPL | 2015-05-13 |
| 35896 | SUPPL | 2014-12-18 |
| 26497 | SUPPL | 2014-11-14 |
| 14173 | SUPPL | 2014-06-23 |
| 4055 | SUPPL | 2014-06-23 |
| 26496 | SUPPL | 2013-05-22 |
| 14172 | SUPPL | 2013-05-20 |
| 26495 | SUPPL | 2012-09-24 |
| 14171 | SUPPL | 2012-09-24 |
| 26494 | SUPPL | 2011-12-05 |
| 35895 | SUPPL | 2011-12-02 |
| 23987 | ORIG | 2011-04-04 |
| 4054 | SUPPL | 2011-03-14 |
| 14170 | SUPPL | 2011-03-11 |
| 4053 | SUPPL | 2009-10-26 |
| 14169 | SUPPL | 2009-10-01 |
| 26493 | SUPPL | 2008-01-09 |
| 4052 | SUPPL | 2008-01-09 |
| 4051 | SUPPL | 2008-01-09 |
| 35894 | SUPPL | 2008-01-08 |
| 14168 | SUPPL | 2008-01-08 |
| 35893 | SUPPL | 2007-12-14 |
| 21355 | SUPPL | 2006-06-01 |
| 21354 | SUPPL | 2006-06-01 |
| 35892 | SUPPL | 2005-08-19 |
| 4050 | SUPPL | 2005-08-19 |
| 4048 | SUPPL | 2005-08-16 |
| 14167 | SUPPL | 2004-12-03 |
| 4049 | SUPPL | 2004-12-02 |
| 21353 | ORIG | 2004-01-15 |
| 26492 | SUPPL | 2003-09-30 |
| 26491 | SUPPL | 2003-09-29 |
| 35891 | SUPPL | 2002-10-22 |
| 4047 | SUPPL | 2002-10-22 |
| 14166 | ORIG | 2000-02-28 |
| 4046 | ORIG | 2000-02-28 |
| 53130 | ORIG | 1900-01-01 |
| 53129 | ORIG | 1900-01-01 |
| 53128 | ORIG | 1900-01-01 |
| 53127 | ORIG | 1900-01-01 |
| 53126 | ORIG | 1900-01-01 |
| 53125 | ORIG | 1900-01-01 |