Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076526
Company: TARO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUOROURACIL FLUOROURACIL 2% SOLUTION;TOPICAL Prescription AT No No
FLUOROURACIL FLUOROURACIL 5% SOLUTION;TOPICAL Prescription AT 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
11/05/2003 ORIG-1 Approval

Label is not available on this site.

FLUOROURACIL

SOLUTION;TOPICAL; 2%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EFUDEX FLUOROURACIL 2% SOLUTION;TOPICAL Prescription Yes AT 016831 BAUSCH
FLUOROURACIL FLUOROURACIL 2% SOLUTION;TOPICAL Prescription No AT 076526 TARO

SOLUTION;TOPICAL; 5%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EFUDEX FLUOROURACIL 5% SOLUTION;TOPICAL Prescription Yes AT 016831 BAUSCH
FLUOROURACIL FLUOROURACIL 5% SOLUTION;TOPICAL Prescription No AT 076526 TARO

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