| Product NDC: | 0078-0476 |
| Proprietary Name: | Zaditor |
| Non Proprietary Name: | Ketotifen Fumarate |
| Active Ingredient(s): | .345 mg/mL & nbsp; Ketotifen Fumarate |
| Administration Route(s): | OPHTHALMIC |
| Dosage Form(s): | SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0078-0476 |
| Labeler Name: | Novartis Pharmaceuticals Corporation |
| Product Type: | HUMAN OTC DRUG |
| FDA Application Number: | NDA021066 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20090922 |
| Package NDC: | 0078-0476-61 |
| Package Description: | 1 BOTTLE, DROPPER in 1 CARTON (0078-0476-61) > 5 mL in 1 BOTTLE, DROPPER |
| NDC Code | 0078-0476-61 |
| Proprietary Name | Zaditor |
| Package Description | 1 BOTTLE, DROPPER in 1 CARTON (0078-0476-61) > 5 mL in 1 BOTTLE, DROPPER |
| Product NDC | 0078-0476 |
| Product Type Name | HUMAN OTC DRUG |
| Non Proprietary Name | Ketotifen Fumarate |
| Dosage Form Name | SOLUTION |
| Route Name | OPHTHALMIC |
| Start Marketing Date | 20090922 |
| Marketing Category Name | NDA |
| Labeler Name | Novartis Pharmaceuticals Corporation |
| Substance Name | KETOTIFEN FUMARATE |
| Strength Number | .345 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes |