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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021055
Company: VALEANT LUXEMBOURG

Products on NDA 021055

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TARGRETIN	BEXAROTENE	75MG	CAPSULE;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021055

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.

Labels for NDA 021055

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

Therapeutic Equivalents for NDA 021055

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	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

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