Product NDC: | 0078-0500 |
Proprietary Name: | Lamisil |
Non Proprietary Name: | terbinafine hydrochloride |
Active Ingredient(s): | 187.5 mg/1 & nbsp; terbinafine hydrochloride |
Administration Route(s): | ORAL |
Dosage Form(s): | GRANULE |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0078-0500 |
Labeler Name: | Novartis Pharmaceuticals Corporation |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA022071 |
Marketing Category: | NDA |
Start Marketing Date: | 20070928 |
Package NDC: | 0078-0500-58 |
Package Description: | 14 PACKET in 1 CARTON (0078-0500-58) > 1 GRANULE in 1 PACKET (0078-0500-62) |
NDC Code | 0078-0500-58 |
Proprietary Name | Lamisil |
Package Description | 14 PACKET in 1 CARTON (0078-0500-58) > 1 GRANULE in 1 PACKET (0078-0500-62) |
Product NDC | 0078-0500 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | terbinafine hydrochloride |
Dosage Form Name | GRANULE |
Route Name | ORAL |
Start Marketing Date | 20070928 |
Marketing Category Name | NDA |
Labeler Name | Novartis Pharmaceuticals Corporation |
Substance Name | TERBINAFINE HYDROCHLORIDE |
Strength Number | 187.5 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] |