| Product NDC: | 0168-0099 |
| Proprietary Name: | ketoconazole |
| Non Proprietary Name: | ketoconazole |
| Active Ingredient(s): | 20 mg/g & nbsp; ketoconazole |
| Administration Route(s): | TOPICAL |
| Dosage Form(s): | CREAM |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0168-0099 |
| Labeler Name: | E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA076294 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20040428 |
| Package NDC: | 0168-0099-60 |
| Package Description: | 1 TUBE in 1 CARTON (0168-0099-60) > 60 g in 1 TUBE |
| NDC Code | 0168-0099-60 |
| Proprietary Name | ketoconazole |
| Package Description | 1 TUBE in 1 CARTON (0168-0099-60) > 60 g in 1 TUBE |
| Product NDC | 0168-0099 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | ketoconazole |
| Dosage Form Name | CREAM |
| Route Name | TOPICAL |
| Start Marketing Date | 20040428 |
| Marketing Category Name | ANDA |
| Labeler Name | E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. |
| Substance Name | KETOCONAZOLE |
| Strength Number | 20 |
| Strength Unit | mg/g |
| Pharmaceutical Classes | Azole Antifungal [EPC],Azoles [Chemical/Ingredient] |