Application 014399
- Type
- NDA
- Sponsor
- US PHARM HOLDINGS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NORPRAMIN | DESIPRAMINE HYDROCHLORIDE | TABLET;ORAL | 25MG | Yes | No |
| 003 | NORPRAMIN | DESIPRAMINE HYDROCHLORIDE | TABLET;ORAL | 50MG | Yes | No |
| 004 | NORPRAMIN | DESIPRAMINE HYDROCHLORIDE | TABLET;ORAL | 75MG | Yes | No |
| 005 | NORPRAMIN | DESIPRAMINE HYDROCHLORIDE | TABLET;ORAL | 100MG | Yes | Yes |
| 006 | NORPRAMIN | DESIPRAMINE HYDROCHLORIDE | TABLET;ORAL | 150MG | Yes | No |
| 007 | NORPRAMIN | DESIPRAMINE HYDROCHLORIDE | TABLET;ORAL | 10MG | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0068-0007 | Norpramin | desipramine hydrochloride | sanofi-aventis U.S. LLC | NDA | Current |
| 0955-1030 | Desipramine Hydrochloride | desipramine hydrochloride | Winthrop U.S. | NDA AUTHORIZED GENERIC | Current |
| 30698-007 | Norpramin | desipramine hydrochloride | Validus Pharmaceuticals LLC | NDA | Current |
| 30698-007 | Norpramin | desipramine hydrochloride | Validus Pharmaceuticals LLC | NDA | Current |
| 30698-011 | Norpramin | desipramine hydrochloride | Validus Pharmaceuticals LLC | NDA | Current |
| 30698-011 | Norpramin | desipramine hydrochloride | Validus Pharmaceuticals LLC | NDA | Current |
| 30698-015 | Norpramin | desipramine hydrochloride | Validus Pharmaceuticals LLC | NDA | Current |
| 30698-015 | Norpramin | desipramine hydrochloride | Validus Pharmaceuticals LLC | NDA | Current |
| 30698-019 | Norpramin | desipramine hydrochloride | Validus Pharmaceuticals LLC | NDA | Current |
| 30698-019 | Norpramin | desipramine hydrochloride | Validus Pharmaceuticals LLC | NDA | Current |
| 30698-020 | Norpramin | desipramine hydrochloride | Validus Pharmaceuticals LLC | NDA | Current |
| 30698-020 | Norpramin | desipramine hydrochloride | Validus Pharmaceuticals LLC | NDA | Current |
| 30698-021 | Norpramin | desipramine hydrochloride | Validus Pharmaceuticals LLC | NDA | Current |
| 30698-021 | Norpramin | desipramine hydrochloride | Validus Pharmaceuticals LLC | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 82715 | SUPPL | 2025-06-30 |
| 82661 | SUPPL | 2025-06-25 |
| 56444 | SUPPL | 2018-11-15 |
| 56418 | SUPPL | 2018-11-13 |
| 10843 | SUPPL | 2014-07-03 |
| 377 | SUPPL | 2014-07-03 |
| 33121 | SUPPL | 2012-11-26 |
| 33120 | SUPPL | 2012-11-26 |
| 23096 | SUPPL | 2012-11-26 |
| 12065 | SUPPL | 2012-11-21 |
| 376 | SUPPL | 2012-11-21 |
| 12064 | SUPPL | 2009-11-19 |
| 10842 | SUPPL | 2009-10-30 |
| 33119 | SUPPL | 2007-07-31 |
| 12063 | SUPPL | 2007-07-31 |
| 44003 | ORIG | 2007-05-09 |
| 375 | SUPPL | 2006-04-13 |
| 10841 | SUPPL | 2006-04-12 |
| 33118 | SUPPL | 2005-01-13 |
| 374 | SUPPL | 2005-01-13 |