Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019339
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER HEPARIN SODIUM 10,000 UNITS/100ML INJECTABLE;INJECTION Prescription AP No No
HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER HEPARIN SODIUM 5,000 UNITS/100ML INJECTABLE;INJECTION Prescription None No No
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER HEPARIN SODIUM 10,000 UNITS/100ML INJECTABLE;INJECTION Prescription AP No No
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER HEPARIN SODIUM 5,000 UNITS/100ML INJECTABLE;INJECTION Prescription AP 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
03/27/1985 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
12/20/2018 SUPPL-62 Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019339s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019339Orig1s62Ltr.pdf
03/13/2014 SUPPL-54 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019339s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019339Orig1s054ltr.pdf
09/04/2019 SUPPL-52 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018916s063,019339s052,019805s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/018916Orig1s063, 019339Orig1s052, 019805Orig1s034ltr.pdf
02/08/2013 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

12/23/2011 SUPPL-47 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019339s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019339s047ltr.pdf
07/23/2009 SUPPL-38 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019339s038ltr.pdf
10/17/2008 SUPPL-34 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019339s034ltr.pdf
11/07/2002 SUPPL-25 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/19/1999 SUPPL-24 Labeling

Label is not available on this site.

10/27/1998 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

10/27/1998 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

03/16/1998 SUPPL-21 Labeling

Label is not available on this site.

06/09/1997 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

05/27/1998 SUPPL-19 Labeling

Label is not available on this site.

02/07/1996 SUPPL-18 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/24/1995 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

08/30/1996 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

08/22/1995 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/10/1994 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/10/1994 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

11/10/1994 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/10/1994 SUPPL-11 Manufacturing (CMC)-Formulation

Label is not available on this site.

02/25/1992 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

02/18/1992 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/16/1990 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

10/29/1986 SUPPL-4 Manufacturing (CMC)-Formulation

Label is not available on this site.

08/03/1986 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

09/24/1986 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

04/01/1986 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
09/04/2019 SUPPL-52 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018916s063,019339s052,019805s034lbl.pdf
12/20/2018 SUPPL-62 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019339s062lbl.pdf
12/20/2018 SUPPL-62 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019339s062lbl.pdf
03/13/2014 SUPPL-54 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019339s054lbl.pdf
12/23/2011 SUPPL-47 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019339s047lbl.pdf

HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

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

HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

There are no Therapeutic Equivalents.

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

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

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

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