Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017651
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HEPARIN SODIUM HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE;INJECTION Discontinued None No No
HEPARIN SODIUM HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE;INJECTION Discontinued None No No
HEPARIN SODIUM HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE;INJECTION Prescription AP Yes Yes
HEPARIN SODIUM HEPARIN SODIUM 20,000 UNITS/ML 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
02/10/1978 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/pre96/017651_ORIGINAL APPROVAL_PACKAGE.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/15/2016 SUPPL-62 Manufacturing (CMC)

Label is not available on this site.

07/18/2013 SUPPL-60 Manufacturing (CMC)

Label is not available on this site.

03/21/2014 SUPPL-59 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017029Orig1s135,017651Orig1s059.pdf
11/13/2015 SUPPL-58 Manufacturing (CMC)

Label is not available on this site.

03/20/2013 SUPPL-57 Manufacturing (CMC)

Label is not available on this site.

02/16/2013 SUPPL-56 Manufacturing (CMC)

Label is not available on this site.

12/23/2011 SUPPL-55 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017029s131017651s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017029s131,017651s055ltr.pdf
06/24/2011 SUPPL-52 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017029s128,017651s052ltr.pdf
06/11/2010 SUPPL-48 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017029s120,017651s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017029s120,017651s048ltr.pdf
04/01/2009 SUPPL-46 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017651s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017651s046ltr.pdf
12/14/2007 SUPPL-42 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017651s042ltr.pdf
01/07/2003 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

12/13/1999 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

12/22/1997 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

12/22/1992 SUPPL-31 Labeling

Label is not available on this site.

07/31/1992 SUPPL-30 Labeling

Label is not available on this site.

07/12/1995 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

07/26/1996 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

08/25/1993 SUPPL-25 Labeling

Label is not available on this site.

02/09/1989 SUPPL-23 Labeling

Label is not available on this site.

10/19/1988 SUPPL-22 Labeling

Label is not available on this site.

01/08/1985 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

07/29/1985 SUPPL-20 Labeling

Label is not available on this site.

09/19/1984 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

10/04/1984 SUPPL-18 Labeling

Label is not available on this site.

06/26/1984 SUPPL-16 Efficacy

Label is not available on this site.

12/19/1983 SUPPL-15 Efficacy

Label is not available on this site.

01/12/1983 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

04/06/1982 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

06/02/1981 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

01/21/1980 SUPPL-11 Labeling

Label is not available on this site.

10/18/1979 SUPPL-10 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/18/1979 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

01/25/1980 SUPPL-8 Labeling

Label is not available on this site.

05/29/1979 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

01/08/1979 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

10/03/1979 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

01/08/1979 SUPPL-4 Labeling

Label is not available on this site.

07/13/1979 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

01/08/1979 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

11/15/1978 SUPPL-1 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
12/23/2011 SUPPL-55 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017029s131017651s055lbl.pdf
06/11/2010 SUPPL-48 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017029s120,017651s048lbl.pdf
04/01/2009 SUPPL-46 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017651s046lbl.pdf

HEPARIN SODIUM

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HEPARIN SODIUM HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 091659 CASI PHARMS INC
HEPARIN SODIUM HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE;INJECTION Prescription Yes AP 017651 FRESENIUS KABI USA
HEPARIN SODIUM HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 206552 FRESENIUS KABI USA
HEPARIN SODIUM HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 205323 GLAND PHARMA LTD
HEPARIN SODIUM HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE;INJECTION Prescription Yes AP 017037 HIKMA
HEPARIN SODIUM HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 090571 HOSPIRA INC
HEPARIN SODIUM HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 203851 MYLAN LABS LTD
HEPARIN SODIUM HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 211007 NANJING KING-FRIEND
HEPARIN SODIUM HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 090808 SAGENT PHARMS
HEPARIN SODIUM HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 091682 SANDOZ
HEPARIN SODIUM HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 202733 SHENZHEN TECHDOW
HEPARIN SODIUM HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 202957 SHENZHEN TECHDOW
HEPARIN SODIUM IN PLASTIC CONTAINER HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE;INJECTION Prescription Yes AP 017029 FRESENIUS KABI USA

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