Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019805
Company: HOSPIRA
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 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
01/25/1989 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019085Orig1s000rev.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/01/2019 SUPPL-42 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019805s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019805Orig1s042ltr.pdf
03/13/2014 SUPPL-36 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019805s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019805Orig1s036ltr.pdf
09/04/2019 SUPPL-34 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-32 Manufacturing (CMC)

Label is not available on this site.

12/23/2011 SUPPL-29 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019805s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019805s029ltr.pdf
09/18/2002 SUPPL-15 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

03/16/2000 SUPPL-14 Labeling

Label is not available on this site.

11/25/1997 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

05/27/1998 SUPPL-12 Labeling

Label is not available on this site.

08/29/1996 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/24/1995 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

09/05/1996 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

08/30/1996 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

02/25/1992 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

02/18/1992 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/16/1990 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

02/16/1990 SUPPL-3 Manufacturing (CMC)-Control

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-34 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018916s063,019339s052,019805s034lbl.pdf
08/01/2019 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019805s042lbl.pdf
03/13/2014 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019805s036lbl.pdf
12/23/2011 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019805s029lbl.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

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