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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078575
Company: SANDOZ

Products on ANDA 078575

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 078575

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/06/2009	ORIG-1	Approval			Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/078575s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078575s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/11/2020	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
05/11/2020	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
05/09/2016	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
10/28/2011	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
11/14/2014	SUPPL-1	Labeling		Label is not available on this site.

Labels for ANDA 078575

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/06/2009	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/078575s000lbl.pdf

Therapeutic Equivalents for ANDA 078575

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

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