Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207226
Company: FRESENIUS KABI USA

Products on ANDA 207226

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	EQ 500MG BASE/50ML (EQ 10MG BASE/ML)	SOLUTION;INTRAMUSCULAR, INTRAVENOUS	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 207226

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/27/2018	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 207226

LEUCOVORIN CALCIUM

SOLUTION;INTRAMUSCULAR, INTRAVENOUS; EQ 500MG BASE/50ML (EQ 10MG BASE/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	EQ 500MG BASE/50ML (EQ 10MG BASE/ML)	SOLUTION;INTRAMUSCULAR, INTRAVENOUS	Prescription	No	AP	207226	FRESENIUS KABI USA