Ketotifen Fumarate is a Ophthalmic Solution in the Human Otc Drug category. It is labeled and distributed by Rugby Laboratories. The primary component is Ketotifen Fumarate.
| Product ID | 0536-1222_812888bd-5b50-8ece-7a66-83f46279da3e |
| NDC | 0536-1222 |
| Product Type | Human Otc Drug |
| Proprietary Name | Ketotifen Fumarate |
| Generic Name | Ketotifen Fumarate |
| Dosage Form | Solution |
| Route of Administration | OPHTHALMIC |
| Marketing Start Date | 2019-04-24 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA077354 |
| Labeler Name | Rugby Laboratories |
| Substance Name | KETOTIFEN FUMARATE |
| Active Ingredient Strength | 0 mg/mL |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
| Marketing Start Date | 2019-04-24 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA077354 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2019-04-24 |
| Ingredient | Strength |
|---|---|
| KETOTIFEN FUMARATE | .25 mg/mL |
| SPL SET ID: | f1098690-09fa-814b-8caa-dc38042570e4 |
| Manufacturer | |
| UNII |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0179-8601 | Ketotifen Fumarate | Ketotifen Fumarate |
| 0363-9060 | Ketotifen Fumarate | Ketotifen Fumarate |
| 0536-1222 | Ketotifen Fumarate | Ketotifen Fumarate |
| 0536-1252 | Ketotifen Fumarate | Ketotifen Fumarate |
| 17478-717 | Ketotifen Fumarate | Ketotifen Fumarate |
| 69842-600 | Ketotifen Fumarate | Ketotifen Fumarate |
| 69842-601 | Ketotifen Fumarate | Ketotifen Fumarate |
| 70518-1142 | Ketotifen Fumarate | Ketotifen Fumarate |
| 71205-115 | Ketotifen Fumarate | Ketotifen Fumarate |
| 58790-008 | Ketotifen Fumarate | Ketotifen Fumarate |
| 59779-627 | Ketotifen Fumarate | Ketotifen Fumarate |
| 59779-330 | Ketotifen Fumarate | Ketotifen Fumarate |
| 70677-0052 | Ketotifen Fumarate | Ketotifen Fumarate |
| 62011-0379 | Ketotifen Fumarate | Ketotifen Fumarate |
| 60505-6215 | Ketotifen Fumarate | Ketotifen Fumarate |
| 46122-304 | Ketotifen Fumarate | Ketotifen Fumarate |
| 46122-634 | Ketotifen Fumarate | Ketotifen Fumarate |
| 72189-114 | KETOTIFEN FUMARATE | KETOTIFEN FUMARATE |
| 70518-2867 | Ketotifen Fumarate | Ketotifen Fumarate |
| 24208-601 | Alaway | Ketotifen Fumarate |
| 24208-600 | Alaway Preservative Free | ketotifen fumarate |
| 11822-5533 | Eye Itch Releif | Ketotifen Fumarate |
| 0363-0038 | Eye Itch Relief | ketotifen fumarate |
| 0363-0610 | EYE ITCH RELIEF | Ketotifen Fumarate |
| 0536-1096 | Eye Itch Relief | Ketotifen Fumarate |
| 11673-064 | Eye Itch Relief | ketotifen fumarate |
| 11822-4201 | eye itch relief | ketotifen fumarate |
| 11822-4202 | eye itch relief | ketotifen fumarate |
| 21130-601 | Eye Itch Relief | Ketotifen Fumarate |
| 11716-1163 | LEADER EYE ITCH RELIEF DROPS | KETOTIFEN FUMARATE |
| 0065-4011 | Zaditor | ketotifen fumarate |