Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 008107
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM EQ 3MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM EQ 60MG BASE/VIAL FOR SOLUTION;ORAL Discontinued None No No
LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM EQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM EQ 350MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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
06/20/1952 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/17/2003 SUPPL-55 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/08-107scm055ltr.pdf
02/12/2002 SUPPL-54 Labeling Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/08107s54ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/08107s054_LeucovorinTOC.cfm
11/08/1999 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

07/21/1997 SUPPL-51 Labeling

Label is not available on this site.

05/24/1996 SUPPL-50 Labeling

Label is not available on this site.

01/26/1996 SUPPL-49 Manufacturing (CMC)-Control

Label is not available on this site.

12/15/1992 SUPPL-48 Labeling

Label is not available on this site.

09/11/1990 SUPPL-46 Manufacturing (CMC)-Control

Label is not available on this site.

08/23/1989 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

03/10/1992 SUPPL-42 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/12/1991 SUPPL-40 Efficacy-New Indication

Label is not available on this site.

08/31/1988 SUPPL-39 Efficacy-New Indication

Label is not available on this site.

04/05/1989 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

05/23/1988 SUPPL-36 Manufacturing (CMC)-Formulation

Label is not available on this site.

08/30/1988 SUPPL-35 Labeling

Label is not available on this site.

01/30/1987 SUPPL-34 Labeling

Label is not available on this site.

01/30/1987 SUPPL-33 Efficacy-New Route Of Administration

Label is not available on this site.

01/30/1987 SUPPL-32 Efficacy-New Dosing Regimen

Label is not available on this site.

06/28/1984 SUPPL-31 Manufacturing (CMC)-Formulation

Label is not available on this site.

02/22/1984 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

03/29/1983 SUPPL-29 Labeling

Label is not available on this site.

03/27/1981 SUPPL-27 Labeling

Label is not available on this site.

01/27/1981 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

12/22/1980 SUPPL-25 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/19/1980 SUPPL-24 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/04/1980 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

02/05/1980 SUPPL-22 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/16/1980 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

04/28/1980 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

07/25/1979 SUPPL-19 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/07/1979 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

03/06/1979 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

03/06/1979 SUPPL-16 Manufacturing (CMC)-Formulation

Label is not available on this site.

03/09/1979 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

11/11/1977 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

08/15/1977 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

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