| Product NDC: | 58790-008 |
| Proprietary Name: | Ketotifen Fumarate |
| Non Proprietary Name: | Ketotifen Fumarate |
| Active Ingredient(s): | .35 mg/mL & nbsp; Ketotifen Fumarate |
| Administration Route(s): | OPHTHALMIC |
| Dosage Form(s): | SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 58790-008 |
| Labeler Name: | Advanced Vision Research (Subsidiary of Akorn, Inc.) |
| Product Type: | HUMAN OTC DRUG |
| FDA Application Number: | ANDA077958 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20120315 |
| Package NDC: | 58790-008-05 |
| Package Description: | 1 BOTTLE, DROPPER in 1 CARTON (58790-008-05) > 5 mL in 1 BOTTLE, DROPPER |
| NDC Code | 58790-008-05 |
| Proprietary Name | Ketotifen Fumarate |
| Package Description | 1 BOTTLE, DROPPER in 1 CARTON (58790-008-05) > 5 mL in 1 BOTTLE, DROPPER |
| Product NDC | 58790-008 |
| Product Type Name | HUMAN OTC DRUG |
| Non Proprietary Name | Ketotifen Fumarate |
| Dosage Form Name | SOLUTION |
| Route Name | OPHTHALMIC |
| Start Marketing Date | 20120315 |
| Marketing Category Name | ANDA |
| Labeler Name | Advanced Vision Research (Subsidiary of Akorn, Inc.) |
| Substance Name | KETOTIFEN FUMARATE |
| Strength Number | .35 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes |