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Last Updated: April 13, 2024

Details for New Drug Application (NDA): 018810

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NDA 018810 describes THERMAZENE, which is a drug marketed by Thepharmanetwork Llc and is included in one NDA. It is available from ten suppliers. Additional details are available on the THERMAZENE profile page.

The generic ingredient in THERMAZENE 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 018810
Applicant:Thepharmanetwork Llc
Ingredient:silver sulfadiazine
Formulation / Manufacturing:see details
Pharmacology for NDA: 018810
Medical Subject Heading (MeSH) Categories for 018810
Suppliers and Packaging for NDA: 018810
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
THERMAZENE silver sulfadiazine CREAM;TOPICAL 018810 NDA Medsource Pharmaceuticals 45865-642 45865-642-01 25 g in 1 TUBE (45865-642-01)
THERMAZENE silver sulfadiazine CREAM;TOPICAL 018810 NDA A-S Medication Solutions 50090-0607 50090-0607-0 50 g in 1 JAR (50090-0607-0)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength1%
Approval Date:Dec 23, 1985TE:ABRLD:No

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