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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040147
Company: HOSPIRA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEUCOVORIN CALCIUM PRESERVATIVE FREE LEUCOVORIN CALCIUM EQ 100MG BASE/10ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION;INTRAMUSCULAR, INTRAVENOUS Discontinued None No No
LEUCOVORIN CALCIUM PRESERVATIVE FREE LEUCOVORIN CALCIUM EQ 250MG BASE/25ML (EQ 10MG BASE/ML) SOLUTION;INTRAMUSCULAR, INTRAVENOUS 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
06/25/1997 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
10/05/1998 SUPPL-4 Labeling

Label is not available on this site.
07/07/1998 SUPPL-3 Labeling

Label is not available on this site.
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