| Product NDC: | 0517-0760 |
| Proprietary Name: | Ofloxacin |
| Non Proprietary Name: | Ofloxacin |
| Active Ingredient(s): | 3 mg/mL & nbsp; Ofloxacin |
| Administration Route(s): | OPHTHALMIC |
| Dosage Form(s): | SOLUTION/ DROPS |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0517-0760 |
| Labeler Name: | American Regent, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA076830 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20100701 |
| Package NDC: | 0517-0760-01 |
| Package Description: | 1 BOTTLE in 1 CARTON (0517-0760-01) > 5 mL in 1 BOTTLE |
| NDC Code | 0517-0760-01 |
| Proprietary Name | Ofloxacin |
| Package Description | 1 BOTTLE in 1 CARTON (0517-0760-01) > 5 mL in 1 BOTTLE |
| Product NDC | 0517-0760 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Ofloxacin |
| Dosage Form Name | SOLUTION/ DROPS |
| Route Name | OPHTHALMIC |
| Start Marketing Date | 20100701 |
| Marketing Category Name | ANDA |
| Labeler Name | American Regent, Inc. |
| Substance Name | OFLOXACIN |
| Strength Number | 3 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes | Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] |