Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040347
Company: HIKMA

Products on ANDA 040347

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEUCOVORIN CALCIUM PRESERVATIVE FREE	LEUCOVORIN CALCIUM	EQ 10MG BASE/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040347

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/25/2000	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/40347_Leucovorin%20Calcium_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40347ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/040347_leucovorin-calcium_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/17/2012	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/040347s010lbl.pdf
04/03/2001	SUPPL-1	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.

Labels for ANDA 040347

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/17/2012	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/040347s010lbl.pdf
04/25/2000	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/40347_Leucovorin%20Calcium_Prntlbl.pdf