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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019832
Company: MYLAN INSTITUTIONAL

Products on NDA 019832

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SULFAMYLON	MAFENIDE ACETATE	5%	FOR SOLUTION;TOPICAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019832

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.

Labels for NDA 019832

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

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