Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019952
Company: B BRAUN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER HEPARIN SODIUM 4,000 UNITS/100ML INJECTABLE;INJECTION Prescription AP Yes Yes
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER HEPARIN SODIUM 5,000 UNITS/100ML INJECTABLE;INJECTION Prescription AP Yes Yes
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER HEPARIN SODIUM 10,000 UNITS/100ML INJECTABLE;INJECTION Prescription AP Yes Yes
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
11/03/2018 SUPPL-38 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019952Orig1s038ltr.pdf
11/17/2016 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

05/26/2016 SUPPL-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019952s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019952Orig1s033ltr.pdf
08/30/2013 SUPPL-31 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019952s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019952Orig1s031ltr.pdf
01/09/2013 SUPPL-30 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019952s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019952Orig1s030ltr.pdf
12/23/2011 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019952s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019952s026ltr.pdf
02/26/2009 SUPPL-21 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019952s021lbl.pdf
08/22/2014 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

04/13/2004 SUPPL-12 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19952slr012ltr.pdf
07/12/2002 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

02/15/2002 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/22/2000 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

03/01/2000 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.

07/30/1996 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

12/08/1994 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

12/22/1992 SUPPL-2 Labeling

Label is not available on this site.

03/29/1993 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/26/2016 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019952s033lbl.pdf
08/30/2013 SUPPL-31 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019952s031lbl.pdf
01/09/2013 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019952s030lbl.pdf
12/23/2011 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019952s026lbl.pdf
02/26/2009 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019952s021lbl.pdf

HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 4,000 UNITS/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER HEPARIN SODIUM 4,000 UNITS/100ML INJECTABLE;INJECTION Prescription Yes AP 019952 B BRAUN
HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER HEPARIN SODIUM 4,000 UNITS/100ML INJECTABLE;INJECTION Prescription No AP 019805 HOSPIRA

HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 5,000 UNITS/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER HEPARIN SODIUM 5,000 UNITS/100ML INJECTABLE;INJECTION Prescription Yes AP 019952 B BRAUN
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER HEPARIN SODIUM 5,000 UNITS/100ML INJECTABLE;INJECTION Prescription No AP 019339 HOSPIRA
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER HEPARIN SODIUM 5,000 UNITS/100ML INJECTABLE;INJECTION Prescription No AP 019805 HOSPIRA

INJECTABLE;INJECTION; 10,000 UNITS/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER HEPARIN SODIUM 10,000 UNITS/100ML INJECTABLE;INJECTION Prescription No AP 019339 HOSPIRA
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER HEPARIN SODIUM 10,000 UNITS/100ML INJECTABLE;INJECTION Prescription Yes AP 019952 B BRAUN
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER HEPARIN SODIUM 10,000 UNITS/100ML INJECTABLE;INJECTION Prescription No AP 019339 HOSPIRA

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