Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019832
Company: MYLAN INSTITUTIONAL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SULFAMYLON MAFENIDE ACETATE 5% FOR SOLUTION;TOPICAL Prescription AT Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/05/1998 ORIG-1 Approval Type 3 - New Dosage Form STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/19832lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19832ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19832.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/20/2015 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

06/18/2013 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

12/18/2002 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

05/09/2002 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

09/17/2001 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

07/12/2001 SUPPL-3 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19832s2s3ltr.pdf
07/12/2001 SUPPL-2 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19832s2s3ltr.pdf
09/25/1998 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/05/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/19832lbl.pdf

SULFAMYLON

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 201511 PAR FORM
MAFENIDE ACETATE MAFENIDE ACETATE 5% FOR SOLUTION;TOPICAL Prescription No AT 206716 RICONPHARMA LLC
SULFAMYLON MAFENIDE ACETATE 5% FOR SOLUTION;TOPICAL Prescription Yes AT 019832 MYLAN INSTITUTIONAL

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