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Details for New Drug Application (NDA): 018738

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NDA 018738 describes EXELDERM, which is a drug marketed by Ranbaxy and Sun Pharm Inds Ltd 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 NDA: 018738

Tradename:
EXELDERM
Applicant:
Sun Pharm Inds Ltd
Ingredient:
sulconazole nitrate
Patents:0
Therapeutic Class:Antifungals

Pharmacology for NDA: 018738

Ingredient-typeAzoles

Suppliers and Packaging for NDA: 018738

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EXELDERM
sulconazole nitrate
SOLUTION;TOPICAL 018738 NDA Ranbaxy Laboratories Inc. 10631-100 10631-100-04 2 BOTTLE, PLASTIC in 1 CARTON (10631-100-04) > 30 mL in 1 BOTTLE, PLASTIC
EXELDERM
sulconazole nitrate
SOLUTION;TOPICAL 018738 NDA Ranbaxy Laboratories Inc. 10631-100 10631-100-30 30 mL in 1 BOTTLE, PLASTIC (10631-100-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;TOPICALStrength1%
Approval Date:Aug 30, 1985TE:RLD:Yes

Expired Orange Book Patents for NDA: 018738

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sun Pharm Inds Ltd
EXELDERM
sulconazole nitrate
SOLUTION;TOPICAL018738-001Aug 30, 19854,055,652► subscribe
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