Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077287
Company: FOUGERA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PREDNICARBATE PREDNICARBATE 0.1% CREAM;TOPICAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/19/2006 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077287s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/077287Orig1s000.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/02/2015 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

PREDNICARBATE

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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