Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040174
Company: TEVA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM EQ 350MG BASE/VIAL INJECTABLE;INJECTION Prescription AP No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/12/1997 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/29/2013 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

09/06/2011 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

12/16/1998 SUPPL-2 Labeling

Label is not available on this site.

04/28/1998 SUPPL-1 Labeling

Label is not available on this site.

LEUCOVORIN CALCIUM

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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