Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020279
Company: VALEANT BERMUDA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DERMATOP E EMOLLIENT PREDNICARBATE 0.1% CREAM;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
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.

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

DERMATOP E EMOLLIENT

CREAM;TOPICAL; 0.1%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DERMATOP E EMOLLIENT PREDNICARBATE 0.1% CREAM;TOPICAL Prescription Yes AB 020279 VALEANT BERMUDA
PREDNICARBATE PREDNICARBATE 0.1% CREAM;TOPICAL Prescription No AB 077287 FOUGERA PHARMS

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