FDA.reportPublic FDA data

Application 078983

Type
ANDA
Sponsor
APOTEX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDECAPSULE;ORAL10MGNoNo
002ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDECAPSULE;ORAL18MGNoNo
003ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDECAPSULE;ORAL25MGNoNo
004ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDECAPSULE;ORAL40MGNoNo
005ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDECAPSULE;ORAL60MGNoNo
006ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDECAPSULE;ORAL80MGNoNo
007ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDECAPSULE;ORAL100MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-4235Atomoxetine Hydrochlorideatomoxetine hydrochlorideA-S Medication SolutionsANDACurrent
50090-4235Atomoxetine Hydrochlorideatomoxetine hydrochlorideA-S Medication SolutionsANDACurrent
50090-4235Atomoxetine Hydrochlorideatomoxetine hydrochlorideA-S Medication SolutionsANDACurrent
50090-4235Atomoxetine Hydrochlorideatomoxetine hydrochlorideA-S Medication SolutionsANDACurrent
50090-4236Atomoxetine Hydrochlorideatomoxetine hydrochlorideA-S Medication SolutionsANDACurrent
50090-4236Atomoxetine Hydrochlorideatomoxetine hydrochlorideA-S Medication SolutionsANDACurrent
50090-4236Atomoxetine Hydrochlorideatomoxetine hydrochlorideA-S Medication SolutionsANDACurrent
50090-4237Atomoxetine Hydrochlorideatomoxetine hydrochlorideA-S Medication SolutionsANDACurrent
50090-4237Atomoxetine Hydrochlorideatomoxetine hydrochlorideA-S Medication SolutionsANDACurrent
50090-4237Atomoxetine Hydrochlorideatomoxetine hydrochlorideA-S Medication SolutionsANDACurrent
50090-4243Atomoxetine Hydrochlorideatomoxetine hydrochlorideA-S Medication SolutionsANDACurrent
50090-4243Atomoxetine Hydrochlorideatomoxetine hydrochlorideA-S Medication SolutionsANDACurrent
50090-4243Atomoxetine Hydrochlorideatomoxetine hydrochlorideA-S Medication SolutionsANDACurrent
50090-4243Atomoxetine Hydrochlorideatomoxetine hydrochlorideA-S Medication SolutionsANDACurrent
50090-4244Atomoxetine Hydrochlorideatomoxetine hydrochlorideA-S Medication SolutionsANDACurrent
50090-4244Atomoxetine Hydrochlorideatomoxetine hydrochlorideA-S Medication SolutionsANDACurrent
50090-4244Atomoxetine Hydrochlorideatomoxetine hydrochlorideA-S Medication SolutionsANDACurrent
50090-4244Atomoxetine Hydrochlorideatomoxetine hydrochlorideA-S Medication SolutionsANDACurrent
50268-057Atomoxetine Hydrochlorideatomoxetine hydrochlorideAvPAKANDACurrent
50268-057Atomoxetine Hydrochlorideatomoxetine hydrochlorideAvPAKANDACurrent
50268-057Atomoxetine Hydrochlorideatomoxetine hydrochlorideAvPAKANDACurrent
50268-058Atomoxetine Hydrochlorideatomoxetine hydrochlorideAvPAKANDACurrent
50268-058Atomoxetine Hydrochlorideatomoxetine hydrochlorideAvPAKANDACurrent
50268-058Atomoxetine Hydrochlorideatomoxetine hydrochlorideAvPAKANDACurrent
50268-059Atomoxetine Hydrochlorideatomoxetine hydrochlorideAvPAKANDACurrent
51407-100Atomoxetine Hydrochlorideatomoxetine hydrochlorideGolden State Medical SupplyANDACurrent
51407-100Atomoxetine Hydrochlorideatomoxetine hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-100Atomoxetine Hydrochlorideatomoxetine hydrochlorideGolden State Medical SupplyANDACurrent
51407-100Atomoxetine Hydrochlorideatomoxetine hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-100Atomoxetine Hydrochlorideatomoxetine hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-101Atomoxetine Hydrochlorideatomoxetine hydrochlorideGolden State Medical SupplyANDACurrent
51407-101Atomoxetine Hydrochlorideatomoxetine hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-101Atomoxetine Hydrochlorideatomoxetine hydrochlorideGolden State Medical SupplyANDACurrent
51407-101Atomoxetine Hydrochlorideatomoxetine hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-101Atomoxetine Hydrochlorideatomoxetine hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-102Atomoxetine Hydrochlorideatomoxetine hydrochlorideGolden State Medical SupplyANDACurrent
51407-102Atomoxetine Hydrochlorideatomoxetine hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-102Atomoxetine Hydrochlorideatomoxetine hydrochlorideGolden State Medical SupplyANDACurrent
51407-102Atomoxetine Hydrochlorideatomoxetine hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-102Atomoxetine Hydrochlorideatomoxetine hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-103Atomoxetine Hydrochlorideatomoxetine hydrochlorideGolden State Medical SupplyANDACurrent
51407-103Atomoxetine Hydrochlorideatomoxetine hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-103Atomoxetine Hydrochlorideatomoxetine hydrochlorideGolden State Medical SupplyANDACurrent
51407-103Atomoxetine Hydrochlorideatomoxetine hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-103Atomoxetine Hydrochlorideatomoxetine hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-104Atomoxetine Hydrochlorideatomoxetine hydrochlorideGolden State Medical SupplyANDACurrent
51407-104Atomoxetine Hydrochlorideatomoxetine hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-104Atomoxetine Hydrochlorideatomoxetine hydrochlorideGolden State Medical SupplyANDACurrent
51407-104Atomoxetine Hydrochlorideatomoxetine hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-104Atomoxetine Hydrochlorideatomoxetine hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-105Atomoxetine Hydrochlorideatomoxetine hydrochlorideGolden State Medical SupplyANDACurrent
51407-105Atomoxetine Hydrochlorideatomoxetine hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-105Atomoxetine Hydrochlorideatomoxetine hydrochlorideGolden State Medical SupplyANDACurrent
51407-105Atomoxetine Hydrochlorideatomoxetine hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-105Atomoxetine Hydrochlorideatomoxetine hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-106Atomoxetine Hydrochlorideatomoxetine hydrochlorideGolden State Medical SupplyANDACurrent
51407-106Atomoxetine Hydrochlorideatomoxetine hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-106Atomoxetine Hydrochlorideatomoxetine hydrochlorideGolden State Medical SupplyANDACurrent
51407-106Atomoxetine Hydrochlorideatomoxetine hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-106Atomoxetine Hydrochlorideatomoxetine hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60505-2830Atomoxetine Hydrochlorideatomoxetine hydrochlorideApotex Corp.ANDACurrent
60505-2830Atomoxetine Hydrochlorideatomoxetine hydrochlorideApotex Corp.ANDACurrent
60505-2830Atomoxetine Hydrochlorideatomoxetine hydrochlorideApotex Corp.ANDACurrent
60505-2830Atomoxetine Hydrochlorideatomoxetine hydrochlorideApotex Corp.ANDACurrent
60505-2830Atomoxetine Hydrochlorideatomoxetine hydrochlorideApotex Corp.ANDACurrent
60505-2830Atomoxetine Hydrochlorideatomoxetine hydrochlorideApotex Corp.ANDACurrent
60505-2831Atomoxetine Hydrochlorideatomoxetine hydrochlorideApotex Corp.ANDACurrent
60505-2831Atomoxetine Hydrochlorideatomoxetine hydrochlorideApotex Corp.ANDACurrent
60505-2831Atomoxetine Hydrochlorideatomoxetine hydrochlorideApotex Corp.ANDACurrent
60505-2831Atomoxetine Hydrochlorideatomoxetine hydrochlorideApotex Corp.ANDACurrent
60505-2831Atomoxetine Hydrochlorideatomoxetine hydrochlorideApotex Corp.ANDACurrent
60505-2831Atomoxetine Hydrochlorideatomoxetine hydrochlorideApotex Corp.ANDACurrent
60505-2832Atomoxetine Hydrochlorideatomoxetine hydrochlorideApotex Corp.ANDACurrent
60505-2832Atomoxetine Hydrochlorideatomoxetine hydrochlorideApotex Corp.ANDACurrent
60505-2832Atomoxetine Hydrochlorideatomoxetine hydrochlorideApotex Corp.ANDACurrent
60505-2832Atomoxetine Hydrochlorideatomoxetine hydrochlorideApotex Corp.ANDACurrent
60505-2832Atomoxetine Hydrochlorideatomoxetine hydrochlorideApotex Corp.ANDACurrent
60505-2832Atomoxetine Hydrochlorideatomoxetine hydrochlorideApotex Corp.ANDACurrent
60505-2833Atomoxetine Hydrochlorideatomoxetine hydrochlorideApotex Corp.ANDACurrent
60505-2833Atomoxetine Hydrochlorideatomoxetine hydrochlorideApotex Corp.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
48629ORIG2017-06-02