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) |
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 NDC: | 16110-080-45 |
Package Description: | 1 TUBE in 1 CARTON (16110-080-45) > 45 g in 1 TUBE |
NDC Code | 16110-080-45 |
Proprietary Name | Xolegel |
Package Description | 1 TUBE in 1 CARTON (16110-080-45) > 45 g in 1 TUBE |
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] |