Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018609
Company: BAXTER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HEPARIN SODIUM 1,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HEPARIN SODIUM 200 UNITS/100ML INJECTABLE;INJECTION Prescription AP No No
HEPARIN SODIUM 2,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HEPARIN SODIUM 200 UNITS/100ML INJECTABLE;INJECTION Prescription AP No No
HEPARIN SODIUM 5,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HEPARIN SODIUM 500 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
04/28/1982 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
07/15/2019 SUPPL-54 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018609s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/018609Orig1s054ltr.pdf
07/25/2016 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

08/18/2015 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

08/13/2010 SUPPL-44 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018609s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018609s044ltr.pdf
02/27/2012 SUPPL-42 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018609s042ltr.pdf
08/14/2001 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

11/23/1999 SUPPL-36 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/21/2001 SUPPL-35 Labeling Label (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18609s33s35lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/018609_s035_Heparin_Sodium.pdf
06/01/1999 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

08/21/2001 SUPPL-33 Labeling Label (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18609s33s35lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/018609_s033_Haparin_Sodium.pdf
05/20/1997 SUPPL-32 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/17/1996 SUPPL-31 Labeling

Label is not available on this site.

03/10/1994 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

09/14/1994 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

04/15/1993 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

03/04/1991 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

07/26/1990 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

02/01/1991 SUPPL-23 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/24/1989 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

11/08/1989 SUPPL-21 Labeling

Label is not available on this site.

04/29/1987 SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/01/1986 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

12/01/1986 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

09/20/1985 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

09/20/1985 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/08/1989 SUPPL-15 Labeling

Label is not available on this site.

10/16/1984 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

08/03/1984 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

02/28/1984 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

03/06/1984 SUPPL-11 Labeling

Label is not available on this site.

11/08/1989 SUPPL-10 Labeling

Label is not available on this site.

03/06/1984 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

03/06/1984 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/06/1984 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/09/1982 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/09/1982 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

06/29/1982 SUPPL-1 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/15/2019 SUPPL-54 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018609s054lbl.pdf
08/13/2010 SUPPL-44 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018609s044lbl.pdf
08/21/2001 SUPPL-35 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18609s33s35lbl.pdf
08/21/2001 SUPPL-33 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18609s33s35lbl.pdf

HEPARIN SODIUM 1,000 UNITS AND 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 2,000 UNITS AND 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 5,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

There are no Therapeutic Equivalents.

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