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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212462
Company: QILU

Products on ANDA 212462

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
ABIRATERONE ACETATE	ABIRATERONE ACETATE	500MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212462

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/27/2019	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/28/2022	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
04/05/2021	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 212462

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	208432	TEVA PHARMS USA
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

TABLET;ORAL; 500MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ABIRATERONE ACETATE	ABIRATERONE ACETATE	500MG	TABLET;ORAL	Prescription	No	AB	208327	AMNEAL PHARMS
ABIRATERONE ACETATE	ABIRATERONE ACETATE	500MG	TABLET;ORAL	Prescription	No	AB	208416	DR REDDYS
ABIRATERONE ACETATE	ABIRATERONE ACETATE	500MG	TABLET;ORAL	Prescription	No	AB	215086	FLORIDA
ABIRATERONE ACETATE	ABIRATERONE ACETATE	500MG	TABLET;ORAL	Prescription	No	AB	209227	GLENMARK SPECLT
ABIRATERONE ACETATE	ABIRATERONE ACETATE	500MG	TABLET;ORAL	Prescription	No	AB	210686	MSN
ABIRATERONE ACETATE	ABIRATERONE ACETATE	500MG	TABLET;ORAL	Prescription	No	AB	208446	MYLAN
ABIRATERONE ACETATE	ABIRATERONE ACETATE	500MG	TABLET;ORAL	Prescription	No	AB	215947	NOVUGEN
ABIRATERONE ACETATE	ABIRATERONE ACETATE	500MG	TABLET;ORAL	Prescription	No	AB	212462	QILU
ABIRATERONE ACETATE	ABIRATERONE ACETATE	500MG	TABLET;ORAL	Prescription	No	AB	210726	TEVA PHARMS USA
ZYTIGA	ABIRATERONE ACETATE	500MG	TABLET;ORAL	Prescription	Yes	AB	202379	JANSSEN BIOTECH

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