Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 203122
Company: MYLAN PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUOROURACIL FLUOROURACIL 0.5% 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
04/20/2015 ORIG-1 Approval

Label is not available on this site.

FLUOROURACIL

CREAM;TOPICAL; 0.5%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARAC FLUOROURACIL 0.5% CREAM;TOPICAL Prescription Yes AB 020985 VALEANT PHARMS NORTH
FLUOROURACIL FLUOROURACIL 0.5% CREAM;TOPICAL Prescription No AB 203122 MYLAN PHARMS INC

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