Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019963
Company: VALEANT PHARMS NORTH

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RENOVA TRETINOIN 0.05% CREAM;TOPICAL Prescription AB2 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
12/29/1995 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/08/2013 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.
03/20/2001 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.
08/01/2000 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/19963S5,7LBL.PDF https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19963S5,7LTR.PDF
01/25/1999 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.
08/01/2000 SUPPL-5 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/19963S5,7LBL.PDF https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19963S5,7LTR.PDF
07/23/1998 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.
02/20/1998 SUPPL-3 Labeling

Label is not available on this site.
08/19/1996 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.
08/09/1996 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
08/01/2000 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/19963S5,7LBL.PDF
08/01/2000 SUPPL-5 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/19963S5,7LBL.PDF

RENOVA

CREAM;TOPICAL; 0.05%
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RENOVA TRETINOIN 0.05% CREAM;TOPICAL Prescription Yes AB2 019963 VALEANT PHARMS NORTH
TRETINOIN TRETINOIN 0.05% CREAM;TOPICAL Prescription No AB2 076498 ZO SKIN HEALTH

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