Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212563
Company: TEVA PHARMS USA

Products on ANDA 212563

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FERRIC CITRATE	FERRIC CITRATE	EQ 210MG IRON	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212563

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/11/2026	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/212563Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 212563

FERRIC CITRATE

TABLET;ORAL; EQ 210MG IRON
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AURYXIA	FERRIC CITRATE	EQ 210MG IRON	TABLET;ORAL	Prescription	Yes	AB	205874	KERYX BIOPHARMS
FERRIC CITRATE	FERRIC CITRATE	EQ 210MG IRON	TABLET;ORAL	Prescription	No	AB	212563	TEVA PHARMS USA