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Generated: December 11, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 018737

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NDA 018737 describes EXELDERM, which is a drug marketed by Sun Pharm Inds Inc and is included in two NDAs. It is available from one supplier. Additional details are available on the EXELDERM profile page.

The generic ingredient in EXELDERM is sulconazole nitrate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the sulconazole nitrate profile page.

Summary for 018737

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antifungals

Pharmacology for NDA: 018737

Ingredient-typeAzoles

Suppliers and Packaging for NDA: 018737

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EXELDERM sulconazole nitrate CREAM;TOPICAL 018737 NDA Ranbaxy Laboratories Inc. 10631-101 10631-101-60 60 g in 1 TUBE (10631-101-60)
EXELDERM sulconazole nitrate CREAM;TOPICAL 018737 NDA Ranbaxy Laboratories Inc. 10631-101 10631-101-30 30 g in 1 TUBE (10631-101-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength1%
Approval Date:Feb 28, 1989TE:RLD:Yes


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Serving leading biopharmaceutical companies globally:

McKinsey
AstraZeneca
Harvard Business School
Healthtrust
Johnson and Johnson
Farmers Insurance
Moodys
Chubb
UBS
Queensland Health

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