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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018911
Company: HOSPIRA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% HEPARIN SODIUM 10,000 UNITS/100ML INJECTABLE;INJECTION Discontinued None No No
HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.45% HEPARIN SODIUM 10,000 UNITS/100ML INJECTABLE;INJECTION Discontinued None No No
HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.9% HEPARIN SODIUM 10,000 UNITS/100ML INJECTABLE;INJECTION Discontinued None No No
HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% HEPARIN SODIUM 5,000 UNITS/100ML INJECTABLE;INJECTION Discontinued None No No
HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.9% HEPARIN SODIUM 5,000 UNITS/100ML INJECTABLE;INJECTION Discontinued None No No
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% HEPARIN SODIUM 10,000 UNITS/100ML INJECTABLE;INJECTION Discontinued None No No
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% HEPARIN SODIUM 5,000 UNITS/100ML INJECTABLE;INJECTION Discontinued None No No
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% HEPARIN SODIUM 5,000 UNITS/100ML INJECTABLE;INJECTION Discontinued None No No
HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.45% HEPARIN SODIUM 100 UNITS/ML 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
01/30/1985 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/24/1999 SUPPL-10 Labeling

Label is not available on this site.
05/27/1998 SUPPL-9 Labeling

Label is not available on this site.
08/24/1995 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.
08/29/1996 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.
02/25/1992 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.
07/24/1991 SUPPL-5 Labeling

Label is not available on this site.
09/14/1987 SUPPL-3 Labeling

Label is not available on this site.
09/24/1986 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.
07/29/1985 SUPPL-1 Labeling

Label is not available on this site.
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