Application 021543
- Type
- NDA
- Sponsor
- AUXILIUM PHARMS LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | STRIANT | TESTOSTERONE | TABLET, EXTENDED RELEASE;BUCCAL | 30MG | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 52244-030 | Striant | testosterone | Endo Pharmaceuticals, Inc. | NDA | Current |
| 52244-030 | Striant | testosterone | Endo Pharmaceuticals, Inc. | NDA | Current |
| 52244-030 | Striant | testosterone | Endo Pharmaceuticals Inc. | NDA | Current |
| 55056-3060 | Striant | testosterone | Columbia Laboratories, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 45753 | SUPPL | 2016-11-01 |
| 45675 | SUPPL | 2016-10-27 |
| 37193 | SUPPL | 2015-05-13 |
| 28077 | SUPPL | 2015-05-13 |
| 28076 | SUPPL | 2014-06-23 |
| 15736 | SUPPL | 2014-06-23 |
| 37192 | SUPPL | 2014-03-25 |
| 5689 | SUPPL | 2014-03-25 |
| 28075 | SUPPL | 2004-11-08 |
| 15735 | SUPPL | 2004-11-08 |
| 42206 | ORIG | 2004-10-26 |
| 5688 | SUPPL | 2003-11-28 |
| 15734 | ORIG | 2003-06-22 |
| 5687 | ORIG | 2003-06-22 |