FDA.reportPublic FDA data

Application 079017

Type
ANDA
Sponsor
ZYDUS PHARMS USA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDECAPSULE;ORAL18MGNoNo
002ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDECAPSULE;ORAL25MGNoNo
003ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDECAPSULE;ORAL40MGNoNo
004ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDECAPSULE;ORAL60MGNoNo
005ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDECAPSULE;ORAL80MGNoNo
006ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDECAPSULE;ORAL100MGNoNo
007ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDECAPSULE;ORALEQ 10MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65841-606atomoxetineatomoxetineZydus Lifesciences LimitedANDACurrent
65841-606atomoxetineatomoxetineCadila Healthcare LimitedANDACurrent
65841-606atomoxetineatomoxetineCadila Healthcare LimitedANDACurrent
65841-606atomoxetineatomoxetineCadila Healthcare LimitedANDACurrent
65841-607atomoxetineatomoxetineCadila Healthcare LimitedANDACurrent
65841-607atomoxetineatomoxetineZydus Lifesciences LimitedANDACurrent
65841-607atomoxetineatomoxetineCadila Healthcare LimitedANDACurrent
65841-607atomoxetineatomoxetineCadila Healthcare LimitedANDACurrent
65841-608atomoxetineatomoxetineCadila Healthcare LimitedANDACurrent
65841-608atomoxetineatomoxetineZydus Lifesciences LimitedANDACurrent
65841-608atomoxetineatomoxetineCadila Healthcare LimitedANDACurrent
65841-608atomoxetineatomoxetineCadila Healthcare LimitedANDACurrent
65841-609atomoxetineatomoxetineZydus Lifesciences LimitedANDACurrent
65841-609atomoxetineatomoxetineCadila Healthcare LimitedANDACurrent
65841-609atomoxetineatomoxetineCadila Healthcare LimitedANDACurrent
65841-609atomoxetineatomoxetineCadila Healthcare LimitedANDACurrent
65841-610atomoxetineatomoxetineCadila Healthcare LimitedANDACurrent
65841-610atomoxetineatomoxetineZydus Lifesciences LimitedANDACurrent
65841-610atomoxetineatomoxetineCadila Healthcare LimitedANDACurrent
65841-610atomoxetineatomoxetineCadila Healthcare LimitedANDACurrent
65841-611atomoxetineatomoxetineCadila Healthcare LimitedANDACurrent
65841-611atomoxetineatomoxetineZydus Lifesciences LimitedANDACurrent
65841-611atomoxetineatomoxetineCadila Healthcare LimitedANDACurrent
65841-611atomoxetineatomoxetineCadila Healthcare LimitedANDACurrent
68382-216atomoxetineatomoxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-216atomoxetineatomoxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-216atomoxetineatomoxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-216atomoxetineatomoxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-217atomoxetineatomoxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-217atomoxetineatomoxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-217atomoxetineatomoxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-217atomoxetineatomoxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-218atomoxetineatomoxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-218atomoxetineatomoxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-218atomoxetineatomoxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-218atomoxetineatomoxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-219atomoxetineatomoxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-219atomoxetineatomoxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-219atomoxetineatomoxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-219atomoxetineatomoxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-220atomoxetineatomoxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-220atomoxetineatomoxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-220atomoxetineatomoxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-220atomoxetineatomoxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-223atomoxetineatomoxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-223atomoxetineatomoxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-223atomoxetineatomoxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-223atomoxetineatomoxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent