Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091011
Company: CHARTWELL RX

Products on ANDA 091011

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BICALUTAMIDE	BICALUTAMIDE	50MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091011

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/10/2015	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/091011Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 091011

BICALUTAMIDE

TABLET;ORAL; 50MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BICALUTAMIDE	BICALUTAMIDE	50MG	TABLET;ORAL	Prescription	No	AB	078917	ACCORD HLTHCARE
BICALUTAMIDE	BICALUTAMIDE	50MG	TABLET;ORAL	Prescription	No	AB	079089	ADAPTIS
BICALUTAMIDE	BICALUTAMIDE	50MG	TABLET;ORAL	Prescription	No	AB	200274	APOTEX
BICALUTAMIDE	BICALUTAMIDE	50MG	TABLET;ORAL	Prescription	No	AB	091011	CHARTWELL RX
BICALUTAMIDE	BICALUTAMIDE	50MG	TABLET;ORAL	Prescription	No	AB	078575	SANDOZ
BICALUTAMIDE	BICALUTAMIDE	50MG	TABLET;ORAL	Prescription	No	AB	079110	SUN PHARM
BICALUTAMIDE	BICALUTAMIDE	50MG	TABLET;ORAL	Prescription	No	AB	078634	WATSON LABS TEVA
CASODEX	BICALUTAMIDE	50MG	TABLET;ORAL	Prescription	Yes	AB	020498	ANI PHARMS