Details for New Drug Application (NDA): 016763

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NDA 016763 describes SULFAMYLON, which is a drug marketed by Rising and Mylan Institutional and is included in two NDAs. It is available from one supplier. Additional details are available on the SULFAMYLON profile page.

The generic ingredient in SULFAMYLON is mafenide acetate. There are four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the mafenide acetate profile page.

Summary for 016763

Tradename:	SULFAMYLON
Applicant:	Rising
Ingredient:	mafenide acetate
Patents:	0

Pharmacology for NDA: 016763

Medical Subject Heading (MeSH) Categories for 016763

Anti-Infective Agents, Local

Suppliers and Packaging for NDA: 016763

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SULFAMYLON	mafenide acetate	CREAM;TOPICAL	016763	NDA	Rising Pharma Holdings, Inc.	16571-723	16571-723-12	1 TUBE in 1 CARTON (16571-723-12) / 113.4 g in 1 TUBE
SULFAMYLON	mafenide acetate	CREAM;TOPICAL	016763	NDA	Rising Pharma Holdings, Inc.	16571-723	16571-723-48	453.6 g in 1 JAR (16571-723-48)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	EQ 85MG BASE/GM
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Expired US Patents for NDA 016763

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Rising	SULFAMYLON	mafenide acetate	CREAM;TOPICAL	016763-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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