Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021108
Company: VALEANT PHARMS NORTH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RENOVA TRETINOIN 0.02% CREAM;TOPICAL 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
08/31/2000 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21108lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21108LTr.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-108_Renova.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/25/2016 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

09/22/2014 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

06/13/2014 SUPPL-15 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021108s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021108Orig1s015ltr.pdf
01/08/2013 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

03/20/2001 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/06/2001 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/14/2002 SUPPL-1 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21108s1lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21108slr001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/13/2014 SUPPL-15 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021108s015lbl.pdf
07/14/2002 SUPPL-1 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21108s1lbl.pdf
08/31/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21108lbl.pdf

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