Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 008107
Company: HOSPIRA

Products on NDA 8107

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	EQ 3MG BASE/ML (EQ 3MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	SOLUTION;INTRAMUSCULAR, INTRAVENOUS	Discontinued	None	Yes	No
LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INJECTION	Discontinued	None	Yes	No
LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	EQ 60MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	FOR SOLUTION;ORAL	Discontinued	None	Yes	No
LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	EQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INJECTION	Discontinued	None	Yes	No
LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	EQ 350MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Labels for NDA 008107

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/21/1997	SUPPL-51	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/008107Orig1s051lbl.pdf