FDA.reportPublic FDA data

Application 208706

Type
ANDA
Sponsor
AJANTA PHARMA LTD

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
004DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDECAPSULE, DELAYED REL PELLETS;ORALEQ 40MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
27241-097DuloxetineDuloxetineAjanta Pharma LimitedANDACurrent
27241-097DuloxetineDuloxetineAjanta Pharma LimitedANDACurrent
27241-097DuloxetineDuloxetineAjanta Pharma LimitedANDACurrent
27241-097DuloxetineDuloxetineAjanta Pharma LimitedANDACurrent
27241-097DuloxetineDuloxetineAjanta Pharma USA Inc.ANDACurrent
27241-097DuloxetineDuloxetineAjanta Pharma LimitedANDACurrent
27241-098DuloxetineDuloxetineAjanta Pharma LimitedANDACurrent
27241-098DuloxetineDuloxetineAjanta Pharma LimitedANDACurrent
27241-098DuloxetineDuloxetineAjanta Pharma LimitedANDACurrent
27241-098DuloxetineDuloxetineAjanta Pharma LimitedANDACurrent
27241-098DuloxetineDuloxetineAjanta Pharma USA Inc.ANDACurrent
27241-098DuloxetineDuloxetineAjanta Pharma LimitedANDACurrent
27241-099DuloxetineDuloxetineAjanta Pharma LimitedANDACurrent
27241-099DuloxetineDuloxetineAjanta Pharma LimitedANDACurrent
27241-099DuloxetineDuloxetineAjanta Pharma LimitedANDACurrent
27241-099DuloxetineDuloxetineAjanta Pharma LimitedANDACurrent
27241-099DuloxetineDuloxetineAjanta Pharma USA Inc.ANDACurrent
27241-099DuloxetineDuloxetineAjanta Pharma LimitedANDACurrent
27241-164DuloxetineDuloxetineAjanta Pharma LimitedANDACurrent
27241-164DuloxetineDuloxetineAjanta Pharma LimitedANDACurrent
27241-164DuloxetineDuloxetineAjanta Pharma LimitedANDACurrent
27241-164DuloxetineDuloxetineAjanta Pharma LimitedANDACurrent
27241-164DuloxetineDuloxetineAjanta Pharma USA Inc.ANDACurrent
27241-164DuloxetineDuloxetineAjanta Pharma LimitedANDACurrent
50090-5940DuloxetineDuloxetineA-S Medication SolutionsANDACurrent
50436-0198DuloxetineDuloxetineUnit Dose ServicesANDACurrent
50436-0199DuloxetineDuloxetineUnit Dose ServicesANDACurrent
51655-237DuloxetineDuloxetineNorthwind PharmaceuticalsANDACurrent
53002-1494DuloxetineDuloxetineRPK Pharmaceuticals, Inc.ANDACurrent
53002-1494DuloxetineDuloxetineRPK Pharmaceuticals, Inc.ANDACurrent
53002-1561DuloxetineDuloxetineRPK Pharmaceuticals, Inc.ANDACurrent
53002-1561DuloxetineDuloxetineRPK Pharmaceuticals, Inc.ANDACurrent
55700-605DuloxetineDuloxetineLake Erie Medical DBA QuaANDACurrent
55700-605DuloxetineDuloxetineLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-605DuloxetineDuloxetineLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-605DuloxetineDuloxetineLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-605DuloxetineDuloxetineLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-628DuloxetineDuloxetineLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-628DuloxetineDuloxetineLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-628DuloxetineDuloxetineLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-628DuloxetineDuloxetineLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-628DuloxetineDuloxetineQuality Care Products LLCANDACurrent
55700-628DuloxetineDuloxetineLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-727DuloxetineDuloxetineQuality Care Products, LLCANDACurrent
55700-727DuloxetineDuloxetineQuality Care Products, LLCANDACurrent
55700-727DuloxetineDuloxetineQuality Care Products, LLCANDACurrent
55700-727DuloxetineDuloxetineQuality Care Products, LLCANDACurrent
55700-727DuloxetineDuloxetineQuality Care Products, LLCANDACurrent
60760-461DuloxetineDuloxetineSt. Mary's Medical Park PharmacyANDACurrent
60760-461DuloxetineDuloxetineSt. Mary's Medical Park PharmacyANDACurrent
60760-462DuloxetineDuloxetineSt. Mary's Medical Park PharmacyANDACurrent
63629-8051DuloxetineDuloxetineBryant Ranch PrepackANDACurrent
63629-8051DuloxetineDuloxetineBryant Ranch PrepackANDACurrent
68071-4700DuloxetineDuloxetineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4700DuloxetineDuloxetineNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7672DuloxetineDuloxetinePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7672DuloxetineDuloxetinePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7672DuloxetineDuloxetinePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7935DuloxetineDuloxetinePreferred Pharmaceuticals Inc.ANDACurrent
68788-7935DuloxetineDuloxetinePreferred Pharmaceuticals Inc.ANDACurrent
70518-1011DuloxetineDuloxetineREMEDYREPACK INC.ANDACurrent
70518-1011DuloxetineDuloxetineREMEDYREPACK INC.ANDACurrent
70518-1011DuloxetineDuloxetineREMEDYREPACK INC.ANDACurrent
70518-1011DuloxetineDuloxetineREMEDYREPACK INC.ANDACurrent
70518-1011DuloxetineDuloxetineREMEDYREPACK INC.ANDACurrent
70518-1011DuloxetineDuloxetineREMEDYREPACK INC.ANDACurrent
70518-1054DuloxetineDuloxetineREMEDYREPACK INC.ANDACurrent
70518-1054DuloxetineDuloxetineREMEDYREPACK INC.ANDACurrent
70518-1054DuloxetineDuloxetineREMEDYREPACK INC.ANDACurrent
70518-1054DuloxetineDuloxetineREMEDYREPACK INC.ANDACurrent
70518-1054DuloxetineDuloxetineREMEDYREPACK INC.ANDACurrent
70518-1054DuloxetineDuloxetineREMEDYREPACK INC.ANDACurrent
70518-1054DuloxetineDuloxetineREMEDYREPACK INC.ANDACurrent
70518-1054DuloxetineDuloxetineREMEDYREPACK INC.ANDACurrent
70518-1054DuloxetineDuloxetineREMEDYREPACK INC.ANDACurrent
70518-1054DuloxetineDuloxetineREMEDYREPACK INC.ANDACurrent
70518-1054DuloxetineDuloxetineREMEDYREPACK INC.ANDACurrent
70518-1139DuloxetineDuloxetineREMEDYREPACK INC.ANDACurrent
70518-1139DuloxetineDuloxetineREMEDYREPACK INC.ANDACurrent
70518-1139DuloxetineDuloxetineREMEDYREPACK INC.ANDACurrent