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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021056
Company: BAUSCH

Products on NDA 021056

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TARGRETIN	BEXAROTENE	1%	GEL;TOPICAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021056

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/28/2000	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21056ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-056_Targretin.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/09/2015	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
07/22/2013	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
04/08/2011	SUPPL-3	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021056s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021056s003ltr.pdf
03/14/2002	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 021056

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/08/2011	SUPPL-3	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021056s003lbl.pdf
06/28/2000	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21056lbl.pdf

Therapeutic Equivalents for NDA 021056

TARGRETIN

GEL;TOPICAL; 1%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BEXAROTENE	BEXAROTENE	1%	GEL;TOPICAL	Prescription	No	AB	215398	AMNEAL
TARGRETIN	BEXAROTENE	1%	GEL;TOPICAL	Prescription	Yes	AB	021056	BAUSCH

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