Details for New Drug Application (NDA): 018738

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NDA 018738 describes EXELDERM, which is a drug marketed by Journey and is included in two NDAs. It is available from two suppliers. 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. Two suppliers are listed for this compound. Additional details are available on the sulconazole nitrate profile page.

Summary for 018738

Tradename:	EXELDERM
Applicant:	Journey
Ingredient:	sulconazole nitrate
Patents:	0

Pharmacology for NDA: 018738

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	Sun Pharmaceutical Industries, 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	Sun Pharmaceutical Industries, Inc.	10631-100	10631-100-30	30 mL in 1 BOTTLE, PLASTIC (10631-100-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;TOPICAL			Strength	1%
Approval Date:	Aug 30, 1985	TE:		RLD:	Yes

Expired US Patents for NDA 018738

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Journey	EXELDERM	sulconazole nitrate	SOLUTION;TOPICAL	018738-001	Aug 30, 1985	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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