Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209861
Company: ANI PHARMS

Products on ANDA 209861

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BEXAROTENE	BEXAROTENE	75MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209861

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/08/2018	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/23/2020	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 209861

BEXAROTENE

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