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Generated: November 22, 2018

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Details for New Drug Application (NDA): 021946

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NDA 021946 describes XOLEGEL, which is a drug marketed by Aqua Pharms and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the XOLEGEL profile page.

The generic ingredient in XOLEGEL is ketoconazole. There are fifteen drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the ketoconazole profile page.
Summary for 021946
Tradename:XOLEGEL
Applicant:Aqua Pharms
Ingredient:ketoconazole
Patents:3
Formulation / Manufacturing:see details
Pharmacology for NDA: 021946
Medical Subject Heading (MeSH) Categories for 021946
Suppliers and Packaging for NDA: 021946
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
XOLEGEL ketoconazole GEL;TOPICAL 021946 NDA Aqua Pharmaceuticals 16110-080 16110-080-45 1 TUBE in 1 CARTON (16110-080-45) > 45 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength2%
Approval Date:Jul 28, 2006TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Dec 4, 2018Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF SEBORRHEA DERMATITIS IN HUMANS
Patent:➤ Sign UpPatent Expiration:Nov 24, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Dec 4, 2018Product Flag?YSubstance Flag?Delist Request?

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