Xolegel - 16110-080-02 - (ketoconazole)

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Drug Information of Xolegel

Product NDC: 16110-080
Proprietary Name: Xolegel
Non Proprietary Name: ketoconazole
Active Ingredient(s): 20    mg/g & nbsp;   ketoconazole
Administration Route(s): TOPICAL
Dosage Form(s): GEL
Coding System: National Drug Codes(NDC)

Labeler Information of Xolegel

Product NDC: 16110-080
Labeler Name: Aqua Pharmaceuticals, LLC.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA021946
Marketing Category: NDA
Start Marketing Date: 20060728

Package Information of Xolegel

Package NDC: 16110-080-02
Package Description: 2 g in 1 TUBE (16110-080-02)

NDC Information of Xolegel

NDC Code 16110-080-02
Proprietary Name Xolegel
Package Description 2 g in 1 TUBE (16110-080-02)
Product NDC 16110-080
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name ketoconazole
Dosage Form Name GEL
Route Name TOPICAL
Start Marketing Date 20060728
Marketing Category Name NDA
Labeler Name Aqua Pharmaceuticals, LLC.
Substance Name KETOCONAZOLE
Strength Number 20
Strength Unit mg/g
Pharmaceutical Classes Azole Antifungal [EPC],Azoles [Chemical/Ingredient]

Complete Information of Xolegel


General Information