Product NDC: | 50383-419 |
Proprietary Name: | Ciclopirox |
Non Proprietary Name: | Ciclopirox |
Active Ingredient(s): | 71.3 mg/mL & nbsp; Ciclopirox |
Administration Route(s): | TOPICAL |
Dosage Form(s): | SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 50383-419 |
Labeler Name: | Hi-Tech Pharmacal Co., Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA078270 |
Marketing Category: | ANDA |
Start Marketing Date: | 20070918 |
Package NDC: | 50383-419-06 |
Package Description: | 1 BOTTLE in 1 CARTON (50383-419-06) > 6.6 mL in 1 BOTTLE |
NDC Code | 50383-419-06 |
Proprietary Name | Ciclopirox |
Package Description | 1 BOTTLE in 1 CARTON (50383-419-06) > 6.6 mL in 1 BOTTLE |
Product NDC | 50383-419 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Ciclopirox |
Dosage Form Name | SOLUTION |
Route Name | TOPICAL |
Start Marketing Date | 20070918 |
Marketing Category Name | ANDA |
Labeler Name | Hi-Tech Pharmacal Co., Inc. |
Substance Name | CICLOPIROX |
Strength Number | 71.3 |
Strength Unit | mg/mL |
Pharmaceutical Classes | Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] |