| Product NDC: | 16590-931 |
| Proprietary Name: | OFLOXACIN |
| Non Proprietary Name: | OFLOXACIN |
| Active Ingredient(s): | 3 mg/mL & nbsp; OFLOXACIN |
| Administration Route(s): | AURICULAR (OTIC) |
| Dosage Form(s): | SOLUTION/ DROPS |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 16590-931 |
| Labeler Name: | STAT RX USA LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA076616 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20080317 |
| Package NDC: | 16590-931-05 |
| Package Description: | 1 BOTTLE in 1 CARTON (16590-931-05) > 5 mL in 1 BOTTLE |
| NDC Code | 16590-931-05 |
| Proprietary Name | OFLOXACIN |
| Package Description | 1 BOTTLE in 1 CARTON (16590-931-05) > 5 mL in 1 BOTTLE |
| Product NDC | 16590-931 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | OFLOXACIN |
| Dosage Form Name | SOLUTION/ DROPS |
| Route Name | AURICULAR (OTIC) |
| Start Marketing Date | 20080317 |
| Marketing Category Name | ANDA |
| Labeler Name | STAT RX USA LLC |
| Substance Name | OFLOXACIN |
| Strength Number | 3 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes | Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] |