| 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] |