FDA.reportPublic FDA data

Application 077958

Type
ANDA
Sponsor
AKORN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KETOTIFEN FUMARATEKETOTIFEN FUMARATESOLUTION/DROPS;OPHTHALMICEQ 0.025% BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0179-8601Ketotifen FumarateKetotifen FumarateKAISER FOUNDATION HOSPITALSANDACurrent
0179-8601Ketotifen FumarateKetotifen FumarateKAISER FOUNDATION HOSPITALSANDACurrent
0363-0610EYE ITCH RELIEFKetotifen FumarateWalgreensANDACurrent
0363-9060Ketotifen FumarateKetotifen FumarateWalgreensANDACurrent
0363-9060Ketotifen FumarateKetotifen FumarateWalgreensANDACurrent
0363-9060Ketotifen FumarateKetotifen FumarateWalgreensANDACurrent
0363-9060Ketotifen FumarateKetotifen FumarateWalgreensANDACurrent
0536-1096Eye Itch ReliefKetotifen FumarateRugby LaboratoriesANDACurrent
0536-1096Eye Itch ReliefKetotifen FumarateRugby LaboratoriesANDACurrent
0536-1096Eye Itch ReliefKetotifen FumarateRugby LaboratoriesANDACurrent
0536-1096Eye Itch ReliefKetotifen FumarateRugby LaboratoriesANDACurrent
11822-4201eye itch reliefketotifen fumarateRite Aid CorporationANDACurrent
11822-4201eye itch reliefketotifen fumarateRite Aid CorporationANDACurrent
11822-4201eye itch reliefketotifen fumarateRite Aid CorporationANDACurrent
11822-4201eye itch reliefketotifen fumarateRite Aid CorporationANDACurrent
11822-4202eye itch reliefketotifen fumarateRite Aid CorporationANDACurrent
11822-4202eye itch reliefketotifen fumarateRite Aid CorporationANDACurrent
11822-4202eye itch reliefketotifen fumarateRite Aid CorporationANDACurrent
11822-4202eye itch reliefketotifen fumarateRite Aid CorporationANDACurrent
17478-717Ketotifen FumarateKetotifen FumarateAkornANDACurrent
17478-717Ketotifen FumarateKetotifen FumarateAkornANDACurrent
17478-717Ketotifen FumarateKetotifen FumarateAkorn, Inc.ANDACurrent
17478-717Ketotifen FumarateKetotifen FumarateAkorn, Inc.ANDACurrent
17478-717Ketotifen FumarateKetotifen FumarateAkorn, Inc.ANDACurrent
17478-717Ketotifen FumarateKetotifen FumarateAkornANDACurrent
30142-702Eye ItchKetotifen FumarateKroger CompanyANDACurrent
30142-702Eye ItchKetotifen FumarateKroger CompanyANDACurrent
30142-702Eye ItchKetotifen FumarateKroger CompanyANDACurrent
30142-702Eye ItchKetotifen FumarateKroger CompanyANDACurrent
30142-770Itchy EyeKetotifen FumarateKroger CompanyANDACurrent
37808-802Eye Itch ReliefKetotifen FumarateH E BANDACurrent
37808-802Eye Itch ReliefKetotifen FumarateH E BANDACurrent
37808-802Eye Itch ReliefKetotifen FumarateH E BANDACurrent
37808-802Eye Itch ReliefKetotifen FumarateH E BANDACurrent
37808-870Allergy Eye DropsKetotifen FumarateH E BANDACurrent
37808-870Allergy Eye DropsKetotifen FumarateH E BANDACurrent
37808-870Allergy Eye DropsKetotifen FumarateH E BANDACurrent
37808-870Allergy Eye DropsKetotifen FumarateH E BANDACurrent
41250-302Eye ItchKetotifen FumarateMeijer Distribution IncANDACurrent
41250-302Eye ItchKetotifen FumarateMeijer Distribution IncANDACurrent
41250-302Eye ItchKetotifen FumarateMeijer Distribution IncANDACurrent
41250-302Eye ItchKetotifen FumarateMeijer Distribution IncANDACurrent
41250-302Eye ItchKetotifen FumarateMeijer Distribution IncANDACurrent
41250-303Itchy EyeKetotifen FumarateMeijer Distribution IncANDACurrent
41250-303Itchy EyeKetotifen FumarateMeijer Distribution IncANDACurrent
41250-303Itchy EyeKetotifen FumarateMeijer Distribution IncANDACurrent
41250-303Itchy EyeKetotifen FumarateMeijer Distribution IncANDACurrent
41250-870Itchy EyeKetotifen FumarateMeijer Distribution IncANDACurrent
46122-146Itchy Eye Dropsketotifen fumarateAmerisource BergenANDACurrent
46122-163Eye Itch Reliefketotifen fumarateAmerisource BergenANDACurrent
49348-107eye itch reliefketotifen fumarateSTRATEGIC SOURCING SERVICES LLCANDACurrent
49348-107eye itch reliefketotifen fumarateSTRATEGIC SOURCING SERVICES LLCANDACurrent
49348-107eye itch reliefketotifen fumarateSTRATEGIC SOURCING SERVICES LLCANDACurrent
49348-107eye itch reliefketotifen fumarateSTRATEGIC SOURCING SERVICES LLCANDACurrent
49348-107eye itch reliefketotifen fumarateMcKesson Corporation Valu-RiteANDACurrent
49781-075Eye Itch ReliefKetotifen FumarateCardinal HealthANDACurrent
49781-078Allergy Eye DropsKetotifen FumarateCardinal HealthANDACurrent
50090-2900Ketotifen FumarateKetotifen FumarateA-S Medication SolutionsANDACurrent
50090-2900Ketotifen FumarateKetotifen FumarateA-S Medication SolutionsANDACurrent
50804-302Eye Itch ReliefKetotifen FumarateGood SenseANDACurrent
50804-392Itchy Eye DropsKetotifen FumarateGood SenseANDACurrent
58790-008Ketotifen FumarateKetotifen FumarateAdvanced Vision Research (Subsidiary of Akorn, Inc.)ANDACurrent
58790-301Allergy Eye DropsKetotifen FumarateAdvanced Vision Research (Subsidiary of Akorn, Inc.)ANDACurrent
59779-330Ketotifen FumarateKetotifen FumarateCVS PharmacyANDACurrent
59779-330Ketotifen FumarateKetotifen FumarateCVS PharmacyANDACurrent
59779-330Ketotifen FumarateKetotifen FumarateCVS PharmacyANDACurrent
59779-330Ketotifen FumarateKetotifen FumarateCVS PharmacyANDACurrent
59779-330Ketotifen FumarateKetotifen FumarateCVS PharmacyANDACurrent
59779-330Ketotifen FumarateKetotifen FumarateCVS PharmacyANDACurrent
59779-330Ketotifen FumarateKetotifen FumarateCVS PharmacyANDACurrent
59779-330Ketotifen FumarateKetotifen FumarateCVS PharmacyANDACurrent
59779-627Ketotifen FumarateKetotifen FumarateCVS PharmacyANDACurrent
59779-627Ketotifen FumarateKetotifen FumarateCVS PharmacyANDACurrent
59779-627Ketotifen FumarateKetotifen FumarateCVS PharmacyANDACurrent
59779-627Ketotifen FumarateKetotifen FumarateCVS PharmacyANDACurrent
59779-705Eye Itch ReliefKetotifen FumarateCVS PharmacyANDACurrent
59779-705Eye Itch ReliefKetotifen FumarateCVS PharmacyANDACurrent
59779-705Eye Itch ReliefKetotifen FumarateCVS PharmacyANDACurrent
59779-705Eye Itch ReliefKetotifen FumarateCVS PharmacyANDACurrent
59779-920Eye Itch ReliefKetotifen FumarateCVS PharmacyANDACurrent