FDA.reportPublic FDA data

Application 077354

Type
ANDA
Sponsor
APOTEX INC

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
0536-1222Ketotifen FumarateKetotifen FumarateRugby LaboratoriesANDACurrent
46122-304Ketotifen FumarateKetotifen FumarateAMERISOURCEBERGEN DRUG CORPORATIONANDACurrent
46122-634Ketotifen FumarateKetotifen FumarateAMERISOURCEBERGEN DRUG CORPORATIONANDACurrent
60505-6215Ketotifen FumarateKetotifen FumarateApotex Corp.ANDACurrent
60505-6215Ketotifen FumarateKetotifen FumarateApotex Corp.ANDACurrent
60505-6215Ketotifen FumarateKetotifen FumarateApotex Corp.ANDACurrent
62011-0379Ketotifen FumarateKetotifen FumarateStategic Sourcing Services LLCANDACurrent
62011-0379Ketotifen FumarateKetotifen FumarateStategic Sourcing Services LLCANDACurrent
62011-0379Ketotifen FumarateKetotifen FumarateMcKesson (Healthmart)ANDACurrent
62011-0379Ketotifen FumarateKetotifen FumarateMcKesson (Healthmart)ANDACurrent
62011-0379Ketotifen FumarateKetotifen FumarateStategic Sourcing Services LLCANDACurrent
69842-600Ketotifen FumarateKetotifen FumarateCVS PharmacyANDACurrent
69842-601Ketotifen FumarateKetotifen FumarateCVS PharmacyANDACurrent
70518-2867Ketotifen FumarateKetotifen FumarateREMEDYREPACK INC.ANDACurrent
70518-2867Ketotifen FumarateKetotifen FumarateREMEDYREPACK INC.ANDACurrent
70677-0052Ketotifen FumarateKetotifen FumarateMcKesson (Sunmark)ANDACurrent
70677-0052Ketotifen FumarateKetotifen FumarateStrategic Sourcing Services LLCANDACurrent
70677-0052Ketotifen FumarateKetotifen FumarateStrategic Sourcing Services LLCANDACurrent
70677-0052Ketotifen FumarateKetotifen FumarateMcKesson (Sunmark)ANDACurrent
70677-0052Ketotifen FumarateKetotifen FumarateStrategic Sourcing Services LLCANDACurrent
72189-114KETOTIFEN FUMARATEKETOTIFEN FUMARATEDIRECT RXANDACurrent
72189-114KETOTIFEN FUMARATEKETOTIFEN FUMARATEDIRECT RXANDACurrent
72189-114KETOTIFEN FUMARATEKETOTIFEN FUMARATEDIRECT RXANDACurrent