FDA.report

Application 079022

Type
ANDA
Sponsor
TEVA PHARMS USA

Related Records

Application Products

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

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-3542AtomoxetineAtomoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3542AtomoxetineAtomoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3542AtomoxetineAtomoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3542AtomoxetineAtomoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3542AtomoxetineAtomoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3542AtomoxetineAtomoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3542AtomoxetineAtomoxetineTeva Pharmaceuticals USA,ANDACurrent
0093-3542AtomoxetineAtomoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3542AtomoxetineAtomoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3543AtomoxetineAtomoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3543AtomoxetineAtomoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3543AtomoxetineAtomoxetineTeva Pharmaceuticals USA,ANDACurrent
0093-3543AtomoxetineAtomoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3543AtomoxetineAtomoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3543AtomoxetineAtomoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3543AtomoxetineAtomoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3543AtomoxetineAtomoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3543AtomoxetineAtomoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3544AtomoxetineAtomoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3544AtomoxetineAtomoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3544AtomoxetineAtomoxetineTeva Pharmaceuticals USA,ANDACurrent
0093-3544AtomoxetineAtomoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3544AtomoxetineAtomoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3544AtomoxetineAtomoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3544AtomoxetineAtomoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3544AtomoxetineAtomoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3544AtomoxetineAtomoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3545AtomoxetineAtomoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3545AtomoxetineAtomoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3545AtomoxetineAtomoxetineTeva Pharmaceuticals USA,ANDACurrent
0093-3545AtomoxetineAtomoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3545AtomoxetineAtomoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3545AtomoxetineAtomoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3545AtomoxetineAtomoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3545AtomoxetineAtomoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3545AtomoxetineAtomoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3546AtomoxetineAtomoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3546AtomoxetineAtomoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3546AtomoxetineAtomoxetineTeva Pharmaceuticals USA,ANDACurrent
0093-3546AtomoxetineAtomoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3546AtomoxetineAtomoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3546AtomoxetineAtomoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3546AtomoxetineAtomoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3546AtomoxetineAtomoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3546AtomoxetineAtomoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3547AtomoxetineAtomoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3547AtomoxetineAtomoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3547AtomoxetineAtomoxetineTeva Pharmaceuticals USA,ANDACurrent
0093-3547AtomoxetineAtomoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3547AtomoxetineAtomoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3547AtomoxetineAtomoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3547AtomoxetineAtomoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3547AtomoxetineAtomoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3547AtomoxetineAtomoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3548AtomoxetineAtomoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3548AtomoxetineAtomoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3548AtomoxetineAtomoxetineTeva Pharmaceuticals USA,ANDACurrent
0093-3548AtomoxetineAtomoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3548AtomoxetineAtomoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3548AtomoxetineAtomoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3548AtomoxetineAtomoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3548AtomoxetineAtomoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3548AtomoxetineAtomoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
42291-064AtomoxetineAtomoxetineAvKAREANDACurrent
42291-065AtomoxetineAtomoxetineAvKAREANDACurrent
42291-066AtomoxetineAtomoxetineAvKAREANDACurrent
42291-067AtomoxetineAtomoxetineAvKAREANDACurrent
42291-068AtomoxetineAtomoxetineAvKAREANDACurrent
42291-069AtomoxetineAtomoxetineAvKAREANDACurrent
42291-070AtomoxetineAtomoxetineAvKAREANDACurrent
50090-6254AtomoxetineAtomoxetineA-S Medication SolutionsANDACurrent
50090-6289AtomoxetineAtomoxetineA-S Medication SolutionsANDACurrent

Documents

DocumentSubmission typeDate
48627ORIG2017-06-02