Application 091073
- 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 | 50MG/5GM PACKET | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0591-3524 | Testosterone | Testosterone | Actavis Pharma, Inc. | ANDA | Current |
| 0591-3524 | Testosterone | Testosterone | Actavis Pharma, Inc. | ANDA | Current |
| 0591-3524 | Testosterone | Testosterone | Actavis Pharma, Inc. | ANDA | Current |
| 0591-3524 | Testosterone | Testosterone | Actavis Pharma, Inc. | ANDA | Current |
| 0591-3524 | Testosterone | Testosterone | Actavis Pharma, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 50052 | APPL | 2017-10-12 |
| 49842 | ORIG | 2017-09-22 |