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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 013025
Company: HOSPIRA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
THAM TROMETHAMINE 18GM/500ML (3.6GM/100ML) SOLUTION;INJECTION Prescription None Yes Yes
THAM-E POTASSIUM CHLORIDE; SODIUM CHLORIDE; TROMETHAMINE 370MG/VIAL;1.75GM/VIAL;36GM/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
12/16/1965 ORIG-1 Approval Type 1 - New Molecular Entity and Type 4 - New Combination PRIORITY

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/08/2013 SUPPL-55 Manufacturing (CMC)

Label is not available on this site.
06/25/2013 SUPPL-54 Manufacturing (CMC)

Label is not available on this site.
07/20/2006 SUPPL-40 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/013025s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/013025s040ltr.pdf
02/11/2000 SUPPL-37 Labeling

Label is not available on this site.
02/12/1998 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.
07/26/2000 SUPPL-35 Labeling

Label is not available on this site.
03/29/1996 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.
09/30/1994 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.
01/27/1989 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.
06/12/1986 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.
01/31/1986 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.
11/09/1984 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.
08/03/1984 SUPPL-24 Labeling

Label is not available on this site.
07/05/1983 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.
06/18/1982 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.
12/17/1981 SUPPL-21 Labeling

Label is not available on this site.
01/09/1984 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.
09/27/1982 SUPPL-19 Labeling

Label is not available on this site.
09/27/1982 SUPPL-18 Labeling

Label is not available on this site.
10/14/1980 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.
10/06/1980 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.
06/06/1980 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.
05/29/1980 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.
07/27/1977 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.
12/08/1976 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.
03/01/1976 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.
11/14/1975 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
07/20/2006 SUPPL-40 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/013025s040lbl.pdf
07/20/2006 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/013025s040lbl.pdf
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