| Product NDC: | 0168-0313 |
| Proprietary Name: | ciclopirox olamine |
| Non Proprietary Name: | ciclopirox olamine |
| Active Ingredient(s): | 7.7 mg/g & nbsp; ciclopirox olamine |
| Administration Route(s): | TOPICAL |
| Dosage Form(s): | CREAM |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0168-0313 |
| Labeler Name: | E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA076435 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20041229 |
| Package NDC: | 0168-0313-90 |
| Package Description: | 1 TUBE in 1 CARTON (0168-0313-90) > 90 g in 1 TUBE |
| NDC Code | 0168-0313-90 |
| Proprietary Name | ciclopirox olamine |
| Package Description | 1 TUBE in 1 CARTON (0168-0313-90) > 90 g in 1 TUBE |
| Product NDC | 0168-0313 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | ciclopirox olamine |
| Dosage Form Name | CREAM |
| Route Name | TOPICAL |
| Start Marketing Date | 20041229 |
| Marketing Category Name | ANDA |
| Labeler Name | E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. |
| Substance Name | CICLOPIROX OLAMINE |
| Strength Number | 7.7 |
| Strength Unit | mg/g |
| Pharmaceutical Classes | Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] |