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Drugs@FDA: FDA-Approved Drugs

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

Products on NDA 019963

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RENOVA	TRETINOIN	0.05%	CREAM;TOPICAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019963

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.

Labels for NDA 019963

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

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