Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021055
Company: VALEANT LUXEMBOURG
Company: VALEANT LUXEMBOURG
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TARGRETIN | BEXAROTENE | 75MG | CAPSULE;ORAL | Prescription | AB | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
12/29/1999 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21055ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21055_Targretin.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/14/2015 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/29/2015 | SUPPL-10 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021055s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021055Orig1s010ltr.pdf | |
12/02/2014 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/06/2012 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021055s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021055s008ltr.pdf | |
05/16/2011 | SUPPL-6 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021055s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021055s006ltr.pdf | |
01/29/2002 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/21/2003 | SUPPL-3 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021055s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21055slr002,003ltr.pdf | |
04/21/2003 | SUPPL-2 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021055s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21055slr002,003ltr.pdf | |
02/14/2001 | SUPPL-1 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
07/29/2015 | SUPPL-10 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021055s010lbl.pdf | |
01/06/2012 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021055s008lbl.pdf | |
05/16/2011 | SUPPL-6 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021055s006lbl.pdf | |
04/21/2003 | SUPPL-3 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021055s002lbl.pdf | |
04/21/2003 | SUPPL-2 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021055s002lbl.pdf | |
12/29/1999 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21055lbl.pdf |
TARGRETIN
CAPSULE;ORAL; 75MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BEXAROTENE | BEXAROTENE | 75MG | CAPSULE;ORAL | Prescription | No | AB | 210105 | AMNEAL PHARMS NY |
BEXAROTENE | BEXAROTENE | 75MG | CAPSULE;ORAL | Prescription | No | AB | 209861 | ANI PHARMS |
BEXAROTENE | BEXAROTENE | 75MG | CAPSULE;ORAL | Prescription | No | AB | 208628 | ASCENT PHARMS INC |
BEXAROTENE | BEXAROTENE | 75MG | CAPSULE;ORAL | Prescription | No | AB | 203174 | BIONPHARMA |
BEXAROTENE | BEXAROTENE | 75MG | CAPSULE;ORAL | Prescription | No | AB | 203663 | HIKMA |
BEXAROTENE | BEXAROTENE | 75MG | CAPSULE;ORAL | Prescription | No | AB | 209931 | TEVA PHARMS USA |
BEXAROTENE | BEXAROTENE | 75MG | CAPSULE;ORAL | Prescription | No | AB | 209886 | UPSHER SMITH LABS |
TARGRETIN | BEXAROTENE | 75MG | CAPSULE;ORAL | Prescription | Yes | AB | 021055 | VALEANT LUXEMBOURG |