| Product NDC: | 61314-015 |
| Proprietary Name: | Ofloxacin |
| Non Proprietary Name: | ofloxacin |
| Active Ingredient(s): | 3 mg/mL & nbsp; ofloxacin |
| Administration Route(s): | AURICULAR (OTIC) |
| Dosage Form(s): | SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 61314-015 |
| Labeler Name: | Falcon Pharmaceuticals, Ltd. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA078222 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20080331 |
| Package NDC: | 61314-015-10 |
| Package Description: | 10 mL in 1 BOTTLE (61314-015-10) |
| NDC Code | 61314-015-10 |
| Proprietary Name | Ofloxacin |
| Package Description | 10 mL in 1 BOTTLE (61314-015-10) |
| Product NDC | 61314-015 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | ofloxacin |
| Dosage Form Name | SOLUTION |
| Route Name | AURICULAR (OTIC) |
| Start Marketing Date | 20080331 |
| Marketing Category Name | ANDA |
| Labeler Name | Falcon Pharmaceuticals, Ltd. |
| Substance Name | OFLOXACIN |
| Strength Number | 3 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes | Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] |