TEVA PHARMS USA INC FDA Approval ANDA 211583

ANDA 211583

TEVA PHARMS USA INC

FDA Drug Application

Application #211583

Documents

Letter2022-09-07

Application Sponsors

ANDA 211583TEVA PHARMS USA INC

Marketing Status

None (Tentative Approval)001
None (Tentative Approval)002
None (Tentative Approval)003
None (Tentative Approval)004
None (Tentative Approval)005

Application Products

001TABLET, EXTENDED RELEASE;ORAL2.5MG/1000MG0DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDEDAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE
002TABLET, EXTENDED RELEASE;ORAL5MG/500MG0DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDEDAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE
003TABLET, EXTENDED RELEASE;ORAL5MG/1000MG0DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDEDAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE
004TABLET, EXTENDED RELEASE;ORAL10MG/500MG0DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDEDAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE
005TABLET, EXTENDED RELEASE;ORAL10MG/1000MG0DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDEDAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1TA2022-08-03STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

TEVA PHARMS USA INC
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    [0] => Array
        (
            [ApplNo] => 211583
            [companyName] => TEVA PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE","activeIngredients":"DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE","strength":"2.5MG\/1000MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE","activeIngredients":"DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE","strength":"5MG\/500MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE","activeIngredients":"DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE","strength":"5MG\/1000MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE","activeIngredients":"DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE","strength":"10MG\/500MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE","activeIngredients":"DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE","strength":"10MG\/1000MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/03\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-08-03
        )

)

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