Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040347
Company: WEST-WARD PHARMS INT
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 Prescription None No Yes
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.

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

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