FDA.reportPublic FDA data

Application 079016

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

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
35573-415AtomoxetineAtomoxetineBurel PharmaANDACurrent
35573-415AtomoxetineAtomoxetineBurel PharmaANDACurrent
35573-415AtomoxetineAtomoxetineBurel Pharmaceuticals, LLCANDACurrent
35573-415AtomoxetineAtomoxetineBurel PharmaANDACurrent
35573-416AtomoxetineAtomoxetineBurel PharmaANDACurrent
35573-416AtomoxetineAtomoxetineBurel Pharmaceuticals, LLCANDACurrent
35573-416AtomoxetineAtomoxetineBurel PharmaANDACurrent
35573-416AtomoxetineAtomoxetineBurel PharmaANDACurrent
35573-417AtomoxetineAtomoxetineBurel PharmaANDACurrent
35573-417AtomoxetineAtomoxetineBurel PharmaANDACurrent
35573-417AtomoxetineAtomoxetineBurel PharmaANDACurrent
35573-417AtomoxetineAtomoxetineBurel Pharmaceuticals, LLCANDACurrent
35573-418AtomoxetineAtomoxetineBurel PharmaANDACurrent
35573-418AtomoxetineAtomoxetineBurel PharmaANDACurrent
35573-418AtomoxetineAtomoxetineBurel PharmaANDACurrent
35573-418AtomoxetineAtomoxetineBurel Pharmaceuticals, LLCANDACurrent
35573-419AtomoxetineAtomoxetineBurel PharmaANDACurrent
35573-419AtomoxetineAtomoxetineBurel Pharmaceuticals, LLCANDACurrent
35573-419AtomoxetineAtomoxetineBurel PharmaANDACurrent
35573-419AtomoxetineAtomoxetineBurel PharmaANDACurrent
35573-420AtomoxetineAtomoxetineBurel PharmaANDACurrent
35573-420AtomoxetineAtomoxetineBurel PharmaANDACurrent
35573-420AtomoxetineAtomoxetineBurel PharmaANDACurrent
35573-420AtomoxetineAtomoxetineBurel Pharmaceuticals, LLCANDACurrent
35573-421AtomoxetineAtomoxetineBurel Pharmaceuticals, LLCANDACurrent
35573-421AtomoxetineAtomoxetineBurel PharmaANDACurrent
35573-421AtomoxetineAtomoxetineBurel PharmaANDACurrent
35573-421AtomoxetineAtomoxetineBurel PharmaANDACurrent
60687-326AtomoxetineAtomoxetineAmerican Health PackagingANDACurrent
60687-326AtomoxetineAtomoxetineAmerican Health PackagingANDACurrent
60687-326AtomoxetineAtomoxetineAmerican Health PackagingANDACurrent
60687-326AtomoxetineAtomoxetineAmerican Health PackagingANDACurrent
60687-326AtomoxetineAtomoxetineAmerican Health PackagingANDACurrent
60687-567AtomoxetineAtomoxetineAmerican Health PackagingANDACurrent
60687-567AtomoxetineAtomoxetineAmerican Health PackagingANDACurrent
60687-567AtomoxetineAtomoxetineAmerican Health PackagingANDACurrent
64980-373AtomoxetineAtomoxetineRising Pharmaceuticals, Inc.ANDACurrent
64980-373AtomoxetineAtomoxetineRising Pharmaceuticals, Inc.ANDACurrent
64980-373AtomoxetineAtomoxetineRising Pharmaceuticals, Inc.ANDACurrent
64980-373AtomoxetineAtomoxetineRising Pharmaceuticals, Inc.ANDACurrent
64980-374AtomoxetineAtomoxetineRising Pharmaceuticals, Inc.ANDACurrent
64980-374AtomoxetineAtomoxetineRising Pharmaceuticals, Inc.ANDACurrent
64980-374AtomoxetineAtomoxetineRising Pharmaceuticals, Inc.ANDACurrent
64980-374AtomoxetineAtomoxetineRising Pharmaceuticals, Inc.ANDACurrent
64980-375AtomoxetineAtomoxetineRising Pharmaceuticals, Inc.ANDACurrent
64980-375AtomoxetineAtomoxetineRising Pharmaceuticals, Inc.ANDACurrent
64980-375AtomoxetineAtomoxetineRising Pharmaceuticals, Inc.ANDACurrent
64980-375AtomoxetineAtomoxetineRising Pharmaceuticals, Inc.ANDACurrent
64980-376AtomoxetineAtomoxetineRising Pharmaceuticals, Inc.ANDACurrent
64980-376AtomoxetineAtomoxetineRising Pharmaceuticals, Inc.ANDACurrent
64980-376AtomoxetineAtomoxetineRising Pharmaceuticals, Inc.ANDACurrent
64980-376AtomoxetineAtomoxetineRising Pharmaceuticals, Inc.ANDACurrent
64980-377AtomoxetineAtomoxetineRising Pharmaceuticals, Inc.ANDACurrent
64980-377AtomoxetineAtomoxetineRising Pharmaceuticals, Inc.ANDACurrent
64980-377AtomoxetineAtomoxetineRising Pharmaceuticals, Inc.ANDACurrent
64980-377AtomoxetineAtomoxetineRising Pharmaceuticals, Inc.ANDACurrent
64980-378AtomoxetineAtomoxetineRising Pharmaceuticals, Inc.ANDACurrent
64980-378AtomoxetineAtomoxetineRising Pharmaceuticals, Inc.ANDACurrent
64980-378AtomoxetineAtomoxetineRising Pharmaceuticals, Inc.ANDACurrent
64980-378AtomoxetineAtomoxetineRising Pharmaceuticals, Inc.ANDACurrent
64980-379AtomoxetineAtomoxetineRising Pharmaceuticals, Inc.ANDACurrent
64980-379AtomoxetineAtomoxetineRising Pharmaceuticals, Inc.ANDACurrent
64980-379AtomoxetineAtomoxetineRising Pharmaceuticals, Inc.ANDACurrent
64980-379AtomoxetineAtomoxetineRising Pharmaceuticals, Inc.ANDACurrent
65862-238AtomoxetineAtomoxetineAurobindo Pharma LimitedANDACurrent
65862-238AtomoxetineAtomoxetineAurobindo Pharma LimitedANDACurrent
65862-238AtomoxetineAtomoxetineAurobindo Pharma LimitedANDACurrent
65862-238AtomoxetineAtomoxetineAurobindo Pharma LimitedANDACurrent
65862-238AtomoxetineAtomoxetineAurobindo Pharma LimitedANDACurrent
65862-239AtomoxetineAtomoxetineAurobindo Pharma LimitedANDACurrent
65862-239AtomoxetineAtomoxetineAurobindo Pharma LimitedANDACurrent
65862-239AtomoxetineAtomoxetineAurobindo Pharma LimitedANDACurrent
65862-239AtomoxetineAtomoxetineAurobindo Pharma LimitedANDACurrent
65862-239AtomoxetineAtomoxetineAurobindo Pharma LimitedANDACurrent
65862-240AtomoxetineAtomoxetineAurobindo Pharma LimitedANDACurrent
65862-240AtomoxetineAtomoxetineAurobindo Pharma LimitedANDACurrent
65862-240AtomoxetineAtomoxetineAurobindo Pharma LimitedANDACurrent
65862-240AtomoxetineAtomoxetineAurobindo Pharma LimitedANDACurrent
65862-240AtomoxetineAtomoxetineAurobindo Pharma LimitedANDACurrent
65862-241AtomoxetineAtomoxetineAurobindo Pharma LimitedANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
48640ORIG2017-06-05
48632ORIG2017-06-02