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: | 58790-008-10 |
Package Description: | 1 BOTTLE, DROPPER in 1 CARTON (58790-008-10) > 10 mL in 1 BOTTLE, DROPPER |
NDC Code | 58790-008-10 |
Proprietary Name | Ketotifen Fumarate |
Package Description | 1 BOTTLE, DROPPER in 1 CARTON (58790-008-10) > 10 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 |