Application 076744
- Type
- ANDA
- Sponsor
- PAR PHARM
Application Products#
| 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 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 49884-418 | Testosterone | Testosterone | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-418 | Testosterone | Testosterone | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-418 | Testosterone | Testosterone | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-418 | Testosterone | Testosterone | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-418 | Testosterone | Testosterone | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-510 | Testosterone | Testosterone | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-510 | Testosterone | Testosterone | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-510 | Testosterone | Testosterone | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-510 | Testosterone | Testosterone | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-510 | Testosterone | Testosterone | Par Pharmaceutical, Inc. | ANDA | Current |
| 63629-2124 | Testosterone | Testosterone | Bryant Ranch Prepack | ANDA | Current |
| 63629-2124 | Testosterone | Testosterone | Bryant Ranch Prepack | ANDA | Current |
| 63629-2124 | Testosterone | Testosterone | Bryant Ranch Prepack | ANDA | Current |
| 63629-2125 | Testosterone | Testosterone | Bryant Ranch Prepack | ANDA | Current |
| 63629-2125 | Testosterone | Testosterone | Bryant Ranch Prepack | ANDA | Current |
| 64380-151 | Testosterone | Testosterone | Strides Pharma Science Limited | ANDA | Current |
| 64380-152 | Testosterone | Testosterone | Strides Pharma Science Limited | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 43102 | ORIG | 2012-06-28 |