FDA.reportPublic FDA data

Application 202045

Type
ANDA
Sponsor
APOTEX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDECAPSULE, DELAYED REL PELLETS;ORALEQ 20MG BASENoNo
002DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDECAPSULE, DELAYED REL PELLETS;ORALEQ 30MG BASENoNo
003DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDECAPSULE, DELAYED REL PELLETS;ORALEQ 60MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-8034Duloxetine HydrochlorideDuloxetine HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8035Duloxetine HydrochlorideDuloxetine HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0904-6452Duloxetine HydrochlorideDuloxetine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6452Duloxetine HydrochlorideDuloxetine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6452Duloxetine HydrochlorideDuloxetine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6452Duloxetine HydrochlorideDuloxetine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6453Duloxetine HydrochlorideDuloxetine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6453Duloxetine HydrochlorideDuloxetine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6453Duloxetine HydrochlorideDuloxetine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6453Duloxetine HydrochlorideDuloxetine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6453Duloxetine HydrochlorideDuloxetine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6454Duloxetine HydrochlorideDuloxetine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6454Duloxetine HydrochlorideDuloxetine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6454Duloxetine HydrochlorideDuloxetine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6454Duloxetine HydrochlorideDuloxetine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6454Duloxetine HydrochlorideDuloxetine HydrochlorideMajor PharmaceuticalsANDACurrent
50090-3317Duloxetine HydrochlorideDuloxetine HydrochlorideA-S Medication SolutionsANDACurrent
50436-2996Duloxetine HydrochlorideDuloxetine HydrochlorideUnit Dose ServicesANDACurrent
50436-2997Duloxetine HydrochlorideDuloxetine HydrochlorideUnit Dose ServicesANDACurrent
55154-7878Duloxetine HydrochlorideDuloxetine HydrochlorideCardinal HealthANDACurrent
55154-7878Duloxetine HydrochlorideDuloxetine HydrochlorideCardinal HealthANDACurrent
55154-7878Duloxetine HydrochlorideDuloxetine HydrochlorideCardinal HealthANDACurrent
55154-7878Duloxetine HydrochlorideDuloxetine HydrochlorideCardinal HealthANDACurrent
55154-7889Duloxetine HydrochlorideDuloxetine HydrochlorideCardinal HealthANDACurrent
55154-7889Duloxetine HydrochlorideDuloxetine HydrochlorideCardinal HealthANDACurrent
55154-7889Duloxetine HydrochlorideDuloxetine HydrochlorideCardinal HealthANDACurrent
55700-160Duloxetine HydrochlorideDuloxetine HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-160Duloxetine HydrochlorideDuloxetine HydrochlorideLake Erie Medical DBA QuaANDACurrent
55700-165Duloxetine HydrochlorideDuloxetine HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-435Duloxetine HydrochlorideDuloxetine HydrochlorideLake Erie Medical DBA QuaANDACurrent
55700-435Duloxetine HydrochlorideDuloxetine HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
60505-2995Duloxetine HydrochlorideDuloxetine HydrochlorideApotex Corp.ANDACurrent
60505-2995Duloxetine HydrochlorideDuloxetine HydrochlorideApotex Corp.ANDACurrent
60505-2995Duloxetine HydrochlorideDuloxetine HydrochlorideApotex Corp.ANDACurrent
60505-2995Duloxetine HydrochlorideDuloxetine HydrochlorideApotex Corp.ANDACurrent
60505-2995Duloxetine HydrochlorideDuloxetine HydrochlorideApotex Corp.ANDACurrent
60505-2995Duloxetine HydrochlorideDuloxetine HydrochlorideApotex Corp.ANDACurrent
60505-2996Duloxetine HydrochlorideDuloxetine HydrochlorideApotex Corp.ANDACurrent
60505-2996Duloxetine HydrochlorideDuloxetine HydrochlorideApotex Corp.ANDACurrent
60505-2996Duloxetine HydrochlorideDuloxetine HydrochlorideApotex Corp.ANDACurrent
60505-2996Duloxetine HydrochlorideDuloxetine HydrochlorideApotex Corp.ANDACurrent
60505-2996Duloxetine HydrochlorideDuloxetine HydrochlorideApotex Corp.ANDACurrent
60505-2996Duloxetine HydrochlorideDuloxetine HydrochlorideApotex Corp.ANDACurrent
60505-2997Duloxetine HydrochlorideDuloxetine HydrochlorideApotex Corp.ANDACurrent
60505-2997Duloxetine HydrochlorideDuloxetine HydrochlorideApotex Corp.ANDACurrent
60505-2997Duloxetine HydrochlorideDuloxetine HydrochlorideApotex Corp.ANDACurrent
60505-2997Duloxetine HydrochlorideDuloxetine HydrochlorideApotex Corp.ANDACurrent
60505-2997Duloxetine HydrochlorideDuloxetine HydrochlorideApotex Corp.ANDACurrent
60505-2997Duloxetine HydrochlorideDuloxetine HydrochlorideApotex Corp.ANDACurrent
63187-172Duloxetine HydrochlorideDuloxetine HydrochlorideProficient Rx LPANDACurrent
63187-172Duloxetine HydrochlorideDuloxetine HydrochlorideProficient Rx LPANDACurrent
63187-181Duloxetine HydrochlorideDuloxetine HydrochlorideProficient Rx LPANDACurrent
63187-181Duloxetine HydrochlorideDuloxetine HydrochlorideProficient Rx LPANDACurrent
63187-716Duloxetine HydrochlorideDuloxetine HydrochlorideProficient Rx LPANDACurrent
63187-716Duloxetine HydrochlorideDuloxetine HydrochlorideProficient Rx LPANDACurrent
68788-9370Duloxetine HydrochlorideDuloxetine HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9370Duloxetine HydrochlorideDuloxetine HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9371Duloxetine HydrochlorideDuloxetine HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9371Duloxetine HydrochlorideDuloxetine HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
70518-0686Duloxetine HydrochlorideDuloxetine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0716Duloxetine HydrochlorideDuloxetine HydrochlorideREMEDYREPACK INC.ANDACurrent