Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018814
Company: BAXTER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HEPARIN SODIUM 10,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER HEPARIN SODIUM 2,000 UNITS/100ML INJECTABLE;INJECTION Discontinued None No No
HEPARIN SODIUM 20,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER HEPARIN SODIUM 4,000 UNITS/100ML INJECTABLE;INJECTION Discontinued None No No
HEPARIN SODIUM 25,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER HEPARIN SODIUM 5,000 UNITS/100ML INJECTABLE;INJECTION Discontinued None No No
HEPARIN SODIUM 25,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER HEPARIN SODIUM 10,000 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
10/31/1983 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
08/13/2010 SUPPL-32 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018814s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018814s032ltr.pdf
11/23/1999 SUPPL-27 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/19/2000 SUPPL-26 Labeling

Label is not available on this site.

06/01/1999 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

02/04/2000 SUPPL-24 Labeling

Label is not available on this site.

09/17/1996 SUPPL-22 Labeling

Label is not available on this site.

03/10/1994 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

09/14/1994 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

07/20/1994 SUPPL-19 Manufacturing (CMC)-Formulation

Label is not available on this site.

07/20/1994 SUPPL-18 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/15/1993 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

07/16/1991 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

11/19/1992 SUPPL-13 Labeling

Label is not available on this site.

03/04/1991 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

04/25/1991 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

08/24/1989 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

02/19/1988 SUPPL-9 Labeling

Label is not available on this site.

07/08/1987 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/08/1985 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

07/09/1985 SUPPL-6 Efficacy

Label is not available on this site.

06/17/1985 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/31/1985 SUPPL-4 Labeling

Label is not available on this site.

10/16/1984 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

06/08/1984 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
08/13/2010 SUPPL-32 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018814s032lbl.pdf

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