Application 021055
- Type
- NDA
- Sponsor
- VALEANT LUXEMBOURG
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TARGRETIN | BEXAROTENE | CAPSULE;ORAL | 75MG | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0187-5526 | Targretin | bexarotene | Bausch Health US LLC | NDA | Current |
| 0187-5526 | Targretin | bexarotene | Bausch Health US, LLC | NDA | Current |
| 0187-5526 | Targretin | bexarotene | Bausch Health US, LLC | NDA | Current |
| 0187-5526 | Targretin | bexarotene | Valeant Pharmaceuticals North America LLC | NDA | Current |
| 0187-5526 | Targretin | bexarotene | Bausch Health US, LLC | NDA | Current |
| 0187-5526 | Targretin | bexarotene | Bausch Health Americas, Inc. | NDA | Current |
| 0187-5526 | Targretin | bexarotene | Bausch Health US, LLC | NDA | Current |
| 68682-003 | bexarotene | bexarotene | Oceanside Pharmaceuticals | NDA AUTHORIZED GENERIC | Current |
| 68682-003 | bexarotene | bexarotene | Oceanside Pharmaceuticals | NDA AUTHORIZED GENERIC | Current |
| 68682-003 | bexarotene | bexarotene | Oceanside Pharmaceuticals | NDA AUTHORIZED GENERIC | Current |
| 68682-003 | bexarotene | bexarotene | Oceanside Pharmaceuticals | NDA AUTHORIZED GENERIC | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 14255 | SUPPL | 2015-08-04 |
| 26603 | SUPPL | 2015-07-30 |
| 14254 | SUPPL | 2014-03-26 |
| 26602 | SUPPL | 2012-01-09 |
| 4175 | SUPPL | 2011-05-19 |
| 35989 | SUPPL | 2011-05-18 |
| 26601 | SUPPL | 2003-05-29 |
| 4174 | SUPPL | 2003-05-29 |
| 35988 | SUPPL | 2003-04-28 |
| 14253 | SUPPL | 2003-04-28 |
| 41915 | ORIG | 2002-04-11 |
| 35987 | ORIG | 1999-12-29 |
| 4173 | ORIG | 1999-12-29 |