Application 204570
- Type
- ANDA
- Sponsor
- ACTAVIS LABS UT INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TESTOSTERONE | TESTOSTERONE | GEL, METERED;TRANSDERMAL | 1.62% (20.25MG/1.25GM ACTUATION) | No | No |
| 002 | TESTOSTERONE | TESTOSTERONE | GEL;TRANSDERMAL | 1.62% (20.25MG/1.25GM PACKET) | No | No |
| 003 | TESTOSTERONE | TESTOSTERONE | GEL;TRANSDERMAL | 1.62% (40.5MG/2.5GM PACKET) | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0591-2924 | Testosterone | Testosterone | Actavis Pharma, Inc. | ANDA | Current |
| 0591-2924 | Testosterone | Testosterone | Actavis Pharma, Inc. | ANDA | Current |
| 0591-2924 | Testosterone | Testosterone | Actavis Pharma, Inc. | ANDA | Current |
| 0591-2924 | Testosterone | Testosterone | Actavis Pharma, Inc. | ANDA | Current |
| 0591-2924 | Testosterone | Testosterone | Actavis Pharma, Inc. | ANDA | Current |
| 0591-2925 | Testosterone | Testosterone | Actavis Pharma, Inc. | ANDA | Current |
| 0591-2926 | Testosterone | Testosterone | Actavis Pharma, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 57745 | ORIG | 2019-02-21 |
| 55946 | ORIG | 2018-10-15 |
| 55490 | ORIG | 2018-09-14 |
| 54164 | ORIG | 2018-05-11 |
| 49693 | ORIG | 2017-09-07 |