Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021055
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 209861 AMERIGEN PHARMS LTD
BEXAROTENE BEXAROTENE 75MG CAPSULE;ORAL Prescription No AB 210105 AMNEAL PHARMS NY
BEXAROTENE BEXAROTENE 75MG CAPSULE;ORAL Prescription No AB 203174 BIONPHARMA INC
BEXAROTENE BEXAROTENE 75MG CAPSULE;ORAL Prescription No AB 209886 UPSHER SMITH LABS
TARGRETIN BEXAROTENE 75MG CAPSULE;ORAL Prescription Yes AB 021055 VALEANT LUXEMBOURG

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