Product NDC: | 0145-2500 |
Proprietary Name: | ONMEL |
Non Proprietary Name: | itraconazole |
Active Ingredient(s): | 200 mg/1 & nbsp; itraconazole |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0145-2500 |
Labeler Name: | Stiefel Laboratories Inc |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA022484 |
Marketing Category: | NDA |
Start Marketing Date: | 20111201 |
Package NDC: | 0145-2500-63 |
Package Description: | 5 BLISTER PACK in 1 CARTON (0145-2500-63) > 14 TABLET in 1 BLISTER PACK (0145-2500-64) |
NDC Code | 0145-2500-63 |
Proprietary Name | ONMEL |
Package Description | 5 BLISTER PACK in 1 CARTON (0145-2500-63) > 14 TABLET in 1 BLISTER PACK (0145-2500-64) |
Product NDC | 0145-2500 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | itraconazole |
Dosage Form Name | TABLET |
Route Name | ORAL |
Start Marketing Date | 20111201 |
Marketing Category Name | NDA |
Labeler Name | Stiefel Laboratories Inc |
Substance Name | ITRACONAZOLE |
Strength Number | 200 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Azole Antifungal [EPC],Azoles [Chemical/Ingredient] |