Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 019568
Company: VALEANT PHARMS NORTH

Products on NDA 019568

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DERMATOP	PREDNICARBATE	0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	OINTMENT;TOPICAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019568

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/23/1991	ORIG-1	Approval	Type 2 - New Active Ingredient	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-14	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019568s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019568s014ltr.pdf
07/02/2004	SUPPL-8	Manufacturing (CMC)-Formulation	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19568scf008_dermatop_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19568scf008ltr.pdf
09/15/1998	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
06/15/1995	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
01/07/1994	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 019568

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/06/2010	SUPPL-14	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019568s014lbl.pdf
07/02/2004	SUPPL-8	Manufacturing (CMC)-Formulation	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19568scf008_dermatop_lbl.pdf