Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 201370
Company: PFIZER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HEPARIN SODIUM HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE;INJECTION Prescription None Yes Yes
HEPARIN SODIUM HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE;INJECTION Prescription None Yes Yes
HEPARIN SODIUM HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE;INJECTION Prescription None Yes Yes
HEPARIN SODIUM PRESERVATIVE FREE HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE;INJECTION Prescription None 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
07/21/2011 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201370s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201370s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201370_heparin_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201370Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/19/2019 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201370s013s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/201370Orig1s013,s014ltr.pdf
09/19/2019 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201370s013s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/201370Orig1s013,s014ltr.pdf
08/09/2016 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201370s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201370Orig1s010ltr.pdf
12/05/2014 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

03/03/2015 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

04/22/2014 SUPPL-5 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

04/22/2014 SUPPL-4 Labeling-Container/Carton Labels

Label is not available on this site.

12/11/2012 SUPPL-3 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/19/2019 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201370s013s014lbl.pdf
09/19/2019 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201370s013s014lbl.pdf
08/09/2016 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201370s010lbl.pdf
07/21/2011 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201370s000lbl.pdf

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