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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217113
Company: ZYDUS

Products on ANDA 217113

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
APALUTAMIDE	APALUTAMIDE	60MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217113

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/17/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 217113

APALUTAMIDE

TABLET;ORAL; 60MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
APALUTAMIDE	APALUTAMIDE	60MG	TABLET;ORAL	Prescription	No	AB	217113	ZYDUS
ERLEADA	APALUTAMIDE	60MG	TABLET;ORAL	Prescription	Yes	AB	210951	JANSSEN BIOTECH

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