Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018916
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HEPARIN SODIUM 200 UNITS/100ML INJECTABLE;INJECTION Prescription AP Yes Yes
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 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER HEPARIN SODIUM 5,000 UNITS/100ML INJECTABLE;INJECTION Prescription 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 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HEPARIN SODIUM 200 UNITS/100ML INJECTABLE;INJECTION Prescription AP Yes Yes
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER HEPARIN SODIUM 5,000 UNITS/100ML INJECTABLE;INJECTION Prescription None No No
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER HEPARIN SODIUM 10,000 UNITS/100ML INJECTABLE;INJECTION Prescription None No No
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 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
HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9% HEPARIN SODIUM 1,000 UNITS/100ML 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
01/31/1984 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
07/18/2016 SUPPL-70 Manufacturing (CMC)

Label is not available on this site.

04/05/2016 SUPPL-69 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018916s066s069lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018916Orig1s066,s069ltr.pdf
04/14/2015 SUPPL-68 Manufacturing (CMC)

Label is not available on this site.

03/03/2015 SUPPL-67 Manufacturing (CMC)

Label is not available on this site.

04/05/2016 SUPPL-66 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018916s066s069lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018916Orig1s066,s069ltr.pdf
01/15/2014 SUPPL-64 Manufacturing (CMC)

Label is not available on this site.

09/04/2019 SUPPL-63 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
07/15/2013 SUPPL-62 Manufacturing (CMC)

Label is not available on this site.

02/08/2013 SUPPL-61 Manufacturing (CMC)

Label is not available on this site.

02/12/2013 SUPPL-60 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018916s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018916Orig1s060ltr.pdf
11/30/2012 SUPPL-59 Manufacturing (CMC)

Label is not available on this site.

12/23/2011 SUPPL-57 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018916s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018916s057ltr.pdf
11/19/1999 SUPPL-33 Labeling

Label is not available on this site.

10/27/1998 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

08/29/1997 SUPPL-31 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/25/1997 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

06/09/1997 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

08/25/1998 SUPPL-28 Labeling

Label is not available on this site.

04/03/1997 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

08/29/1996 SUPPL-26 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/07/1996 SUPPL-25 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/05/1996 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

08/30/1996 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

10/02/1991 SUPPL-21 Labeling

Label is not available on this site.

02/25/1992 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

10/29/1990 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

02/16/1990 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

10/24/1988 SUPPL-12 Labeling

Label is not available on this site.

06/23/1989 SUPPL-8 Efficacy-New Dosing Regimen

Label is not available on this site.

08/21/1987 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/29/1986 SUPPL-6 Manufacturing (CMC)-Formulation

Label is not available on this site.

08/08/1986 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

10/29/1985 SUPPL-4 Manufacturing (CMC)-Formulation

Label is not available on this site.

10/29/1985 SUPPL-3 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/16/1985 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/24/1984 SUPPL-1 Labeling

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-63 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018916s063,019339s052,019805s034lbl.pdf
04/05/2016 SUPPL-69 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018916s066s069lbl.pdf
04/05/2016 SUPPL-66 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018916s066s069lbl.pdf
02/12/2013 SUPPL-60 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018916s060lbl.pdf
12/23/2011 SUPPL-57 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018916s057lbl.pdf

HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 200 UNITS/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HEPARIN SODIUM 1,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HEPARIN SODIUM 200 UNITS/100ML INJECTABLE;INJECTION Prescription No AP 018609 BAXTER HLTHCARE
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HEPARIN SODIUM 200 UNITS/100ML INJECTABLE;INJECTION Prescription Yes AP 019953 B BRAUN
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HEPARIN SODIUM 200 UNITS/100ML INJECTABLE;INJECTION Prescription Yes AP 018916 HOSPIRA
HEPARIN SODIUM 2,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HEPARIN SODIUM 200 UNITS/100ML INJECTABLE;INJECTION Prescription No AP 018609 BAXTER HLTHCARE
HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HEPARIN SODIUM 200 UNITS/100ML INJECTABLE;INJECTION Prescription Yes AP 018916 HOSPIRA

HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.45%

There are no Therapeutic Equivalents.

HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.9%

There are no Therapeutic Equivalents.

HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

There are no Therapeutic Equivalents.

HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.9%

There are no Therapeutic Equivalents.

HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 200 UNITS/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HEPARIN SODIUM 1,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HEPARIN SODIUM 200 UNITS/100ML INJECTABLE;INJECTION Prescription No AP 018609 BAXTER HLTHCARE
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HEPARIN SODIUM 200 UNITS/100ML INJECTABLE;INJECTION Prescription Yes AP 019953 B BRAUN
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HEPARIN SODIUM 200 UNITS/100ML INJECTABLE;INJECTION Prescription Yes AP 018916 HOSPIRA
HEPARIN SODIUM 2,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HEPARIN SODIUM 200 UNITS/100ML INJECTABLE;INJECTION Prescription No AP 018609 BAXTER HLTHCARE
HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HEPARIN SODIUM 200 UNITS/100ML INJECTABLE;INJECTION Prescription Yes AP 018916 HOSPIRA

HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

There are no Therapeutic Equivalents.

HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

There are no Therapeutic Equivalents.

HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.45%

There are no Therapeutic Equivalents.

HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9%

There are no Therapeutic Equivalents.

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