Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019953
Company: B BRAUN
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/20/1992 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
05/12/2016 SUPPL-32 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019953s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019953Orig1s032ltr.pdf
08/30/2013 SUPPL-30 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019953s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019953Orig1s030ltr.pdf
01/10/2013 SUPPL-29 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019953s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019953Orig1s029ltr.pdf
12/27/2011 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019953s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019953s025ltr.pdf
02/26/2009 SUPPL-21 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019953s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019953s021ltr.pdf
08/22/2014 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

04/13/2004 SUPPL-12 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/019953slr012ltr.pdf
07/12/2002 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

02/15/2002 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/22/2000 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

03/01/2000 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

06/05/1998 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

07/30/1996 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

03/09/1995 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

12/22/1992 SUPPL-3 Labeling

Label is not available on this site.

12/02/1992 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

03/29/1993 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/12/2016 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019953s032lbl.pdf
08/30/2013 SUPPL-30 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019953s030lbl.pdf
08/30/2013 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019953s030lbl.pdf
01/10/2013 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019953s029lbl.pdf
12/27/2011 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019953s025lbl.pdf
02/26/2009 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019953s021lbl.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

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