Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021271
Company: VALEANT PHARMS NORTH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IPRIVASK DESIRUDIN RECOMBINANT 15MG/VIAL INJECTABLE;SUBCUTANEOUS Discontinued None Yes 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
04/04/2003 ORIG-1 Approval Type 2 - New Active Ingredient STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021271lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21271ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-271_Iprivask.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/18/2015 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

11/07/2014 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021271s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021271Orig1s006ltr.pdf
07/01/2014 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

01/21/2010 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/07/2014 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021271s006lbl.pdf
04/04/2003 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021271lbl.pdf

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