Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040335
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 350MG BASE/VIAL INJECTABLE;INJECTION Prescription AP 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
04/20/2000 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40335ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/17/2012 SUPPL-8 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/040347s010lbl.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/17/2012 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/040347s010lbl.pdf

LEUCOVORIN CALCIUM PRESERVATIVE FREE

INJECTABLE;INJECTION; EQ 350MG BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM EQ 350MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 040174 TEVA PHARMS USA
LEUCOVORIN CALCIUM PRESERVATIVE FREE LEUCOVORIN CALCIUM EQ 350MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 203800 MYLAN LABS LTD
LEUCOVORIN CALCIUM PRESERVATIVE FREE LEUCOVORIN CALCIUM EQ 350MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 200855 SAGENT PHARMS
LEUCOVORIN CALCIUM PRESERVATIVE FREE LEUCOVORIN CALCIUM EQ 350MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 040335 WEST-WARD PHARMS INT

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