Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203174
Company: BIONPHARMA

Products on ANDA 203174

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 203174

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/12/2014	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/203174Orig1s000.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/06/2024	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 203174

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	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