Application 076737
- 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;TRANSDERMAL | 25MG/2.5GM PACKET | No | No |
| 002 | TESTOSTERONE | TESTOSTERONE | GEL;TRANSDERMAL | 50MG/5GM PACKET | No | No |
| 003 | TESTOSTERONE | TESTOSTERONE | GEL, METERED;TRANSDERMAL | 12.5MG/1.25GM ACTUATION | No | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0591-2921 | Testosterone | Testosterone | Actavis Pharma, Inc. | ANDA | Current |
| 0591-2921 | Testosterone | Testosterone | Actavis Pharma, Inc. | ANDA | Current |
| 0591-3216 | Testosterone | Testosterone | Actavis Pharma, Inc. | ANDA | Current |
| 0591-3216 | Testosterone | Testosterone | Actavis Pharma, Inc. | ANDA | Current |
| 0591-3217 | Testosterone | Testosterone | Actavis Pharma, Inc. | ANDA | Current |
| 0591-3217 | Testosterone | Testosterone | Actavis Pharma, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 50048 | APPL | 2017-10-12 |
| 31156 | ORIG | 2006-02-02 |