Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201511
Company: PAR FORM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MAFENIDE ACETATE MAFENIDE ACETATE 5% FOR 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
02/12/2013 ORIG-1 Approval Not Applicable Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201511Orig1s000ltr.pdf

MAFENIDE ACETATE

FOR SOLUTION;TOPICAL; 5%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MAFENIDE ACETATE MAFENIDE ACETATE 5% FOR SOLUTION;TOPICAL Prescription No AT 206716 NOVAST LABS
MAFENIDE ACETATE MAFENIDE ACETATE 5% FOR SOLUTION;TOPICAL Prescription No AT 201511 PAR FORM
SULFAMYLON MAFENIDE ACETATE 5% FOR SOLUTION;TOPICAL Prescription Yes AT 019832 MYLAN INSTITUTIONAL

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