Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019568
Company: VALEANT PHARMS NORTH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DERMATOP PREDNICARBATE 0.1% OINTMENT;TOPICAL Prescription AB 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
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.

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

DERMATOP

OINTMENT;TOPICAL; 0.1%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DERMATOP PREDNICARBATE 0.1% OINTMENT;TOPICAL Prescription Yes AB 019568 VALEANT PHARMS NORTH
PREDNICARBATE PREDNICARBATE 0.1% OINTMENT;TOPICAL Prescription No AB 077236 FOUGERA PHARMS

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