Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021756
Company: VALEANT PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MACUGEN PEGAPTANIB SODIUM EQ 0.3MG ACID/0.09ML INJECTABLE;INTRAVITREAL 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
09/17/2004 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021756lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021756ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-756_Macugen.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/26/2017 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

10/12/2011 SUPPL-18 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021756s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021756s018ltr.pdf
04/08/2008 SUPPL-12 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

03/08/2006 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021756s006,s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021756s006,s007ltr.pdf
03/08/2006 SUPPL-6 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021756s006,s007lbl.pdf
11/17/2005 SUPPL-5 Manufacturing (CMC)-Packaging Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021756s004,005ltr.pdf
11/17/2005 SUPPL-4 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021756s004,005ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/12/2011 SUPPL-18 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021756s018lbl.pdf
03/08/2006 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021756s006,s007lbl.pdf
03/08/2006 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021756s006,s007lbl.pdf
09/17/2004 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021756lbl.pdf

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