Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020279
Company: VALEANT BERMUDA

Products on NDA 020279

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DERMATOP E EMOLLIENT	PREDNICARBATE	0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	CREAM;TOPICAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020279

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/29/1993	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
12/06/2010	SUPPL-9	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020279s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020279s009ltr.pdf
09/15/1998	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
02/24/1995	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
05/03/1996	SUPPL-1	Efficacy-New Patient Population		Label is not available on this site.

Labels for NDA 020279

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/06/2010	SUPPL-9	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020279s009lbl.pdf