Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077524
Company: MAYNE PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUOROURACIL FLUOROURACIL 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
04/11/2008 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077524s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/077524_original_approval_pkg.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/29/2014 SUPPL-2 Labeling

Label is not available on this site.

FLUOROURACIL

CREAM;TOPICAL; 5%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EFUDEX FLUOROURACIL 5% CREAM;TOPICAL Prescription Yes AB 016831 BAUSCH
FLUOROURACIL FLUOROURACIL 5% CREAM;TOPICAL Prescription No AB 077524 MAYNE PHARMA
FLUOROURACIL FLUOROURACIL 5% CREAM;TOPICAL Prescription No AB 090368 TARO

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