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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210105
Company: AMNEAL PHARMS NY

Products on ANDA 210105

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 210105

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/04/2018	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 210105

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

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