Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020484
Company: LEO PHARMA AS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INNOHEP TINZAPARIN SODIUM 20,000 IU/ML INJECTABLE;INJECTION Discontinued None No No
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/07/2010 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020484s014lbl.pdf
12/23/2009 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020484s013lbl.pdf
12/29/2008 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020484s011lbl.pdf
07/14/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20484lbl.pdf

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