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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208453
Company: APOTEX

Products on ANDA 208453

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ABIRATERONE ACETATE	ABIRATERONE ACETATE	250MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208453

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/31/2018	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208453Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/22/2021	SUPPL-12	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
11/22/2021	SUPPL-11	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
11/22/2021	SUPPL-9	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
11/22/2021	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 208453

ABIRATERONE ACETATE

TABLET;ORAL; 250MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ABIRATERONE ACETATE	ABIRATERONE ACETATE	250MG	TABLET;ORAL	Prescription	No	AB	208327	AMNEAL PHARMS
ABIRATERONE ACETATE	ABIRATERONE ACETATE	250MG	TABLET;ORAL	Prescription	No	AB	208453	APOTEX
ABIRATERONE ACETATE	ABIRATERONE ACETATE	250MG	TABLET;ORAL	Prescription	No	AB	208416	DR REDDYS
ABIRATERONE ACETATE	ABIRATERONE ACETATE	250MG	TABLET;ORAL	Prescription	No	AB	209227	GLENMARK SPECLT
ABIRATERONE ACETATE	ABIRATERONE ACETATE	250MG	TABLET;ORAL	Prescription	No	AB	208339	HIKMA
ABIRATERONE ACETATE	ABIRATERONE ACETATE	250MG	TABLET;ORAL	Prescription	No	AB	210686	MSN
ABIRATERONE ACETATE	ABIRATERONE ACETATE	250MG	TABLET;ORAL	Prescription	No	AB	208446	MYLAN
ABIRATERONE ACETATE	ABIRATERONE ACETATE	250MG	TABLET;ORAL	Prescription	No	AB	215947	NOVUGEN
ABIRATERONE ACETATE	ABIRATERONE ACETATE	250MG	TABLET;ORAL	Prescription	No	AB	212462	QILU
ABIRATERONE ACETATE	ABIRATERONE ACETATE	250MG	TABLET;ORAL	Prescription	No	AB	208371	RISING
ABIRATERONE ACETATE	ABIRATERONE ACETATE	250MG	TABLET;ORAL	Prescription	No	AB	208380	WOCKHARDT BIO AG
ZYTIGA	ABIRATERONE ACETATE	250MG	TABLET;ORAL	Prescription	Yes	AB	202379	JANSSEN BIOTECH

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