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Last Updated: June 13, 2024

Details for New Drug Application (NDA): 017381

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NDA 017381 describes SILVADENE, which is a drug marketed by King Pharms Llc and is included in one NDA. It is available from three suppliers. Additional details are available on the SILVADENE profile page.

The generic ingredient in SILVADENE is silver sulfadiazine. There are twenty-two drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the silver sulfadiazine profile page.
Summary for 017381
Applicant:King Pharms Llc
Ingredient:silver sulfadiazine
Formulation / Manufacturing:see details
Pharmacology for NDA: 017381
Medical Subject Heading (MeSH) Categories for 017381
Suppliers and Packaging for NDA: 017381
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SILVADENE silver sulfadiazine CREAM;TOPICAL 017381 NDA A-S Medication Solutions 50090-0230 50090-0230-0 1 TUBE in 1 CARTON (50090-0230-0) / 20 g in 1 TUBE
SILVADENE silver sulfadiazine CREAM;TOPICAL 017381 NDA AUTHORIZED GENERIC Greenstone LLC 59762-0131 59762-0131-0 1 TUBE in 1 CARTON (59762-0131-0) / 20 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength1%
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

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