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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019802
Company: B BRAUN

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER HEPARIN SODIUM 5,000 UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None No No
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER HEPARIN SODIUM 10,000 UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None No No
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER HEPARIN SODIUM 5,000 UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None No No
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HEPARIN SODIUM 5,000 UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None No No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
07/20/1992 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
08/22/2014 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.
07/12/2002 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.
02/15/2002 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.
11/22/2000 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.
06/05/1998 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.
12/22/1992 SUPPL-3 Labeling

Label is not available on this site.
12/02/1992 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.
03/29/1993 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.
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