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Details for New Drug Application (NDA): 016763

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NDA 016763 describes SULFAMYLON, which is a drug marketed by 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 three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the mafenide acetate profile page.

Summary for NDA: 016763

Mylan Institutional
mafenide acetate
Therapeutic Class:Antibacterials

Pharmacology for NDA: 016763

Ingredient-typeMethylated Sulfonamides

Suppliers and Packaging for NDA: 016763

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
mafenide acetate
CREAM;TOPICAL 016763 NDA Mylan Institutional Inc. 51079-623 51079-623-81 1 TUBE in 1 CARTON (51079-623-81) > 56.7 g in 1 TUBE
mafenide acetate
CREAM;TOPICAL 016763 NDA Mylan Institutional Inc. 51079-623 51079-623-82 1 TUBE in 1 CARTON (51079-623-82) > 113.4 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrengthEQ 85MG BASE/GM
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Expired Orange Book Patents for NDA: 016763

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mylan Institutional
mafenide acetate
CREAM;TOPICAL016763-001Approved Prior to Jan 1, 19823,497,599<disabled>
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