Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 089628
Company: PHARMACHEMIE USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM EQ 50MG BASE/VIAL INJECTABLE;INJECTION Discontinued None 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
04/17/1997 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
05/06/1998 SUPPL-3 Labeling

Label is not available on this site.

02/24/1998 SUPPL-2 Labeling

Label is not available on this site.

09/15/1998 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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