ANDA 211583

TEVA PHARMS USA INC

FDA Drug Application

Application #211583

Documents

• Letter: 2022-09-07

Application Sponsors

ANDA 211583

TEVA 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

001	TABLET, EXTENDED RELEASE;ORAL	2.5MG/1000MG	0	DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE	DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE
002	TABLET, EXTENDED RELEASE;ORAL	5MG/500MG	0	DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE	DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE
003	TABLET, EXTENDED RELEASE;ORAL	5MG/1000MG	0	DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE	DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE
004	TABLET, EXTENDED RELEASE;ORAL	10MG/500MG	0	DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE	DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE
005	TABLET, EXTENDED RELEASE;ORAL	10MG/1000MG	0	DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE	DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-08-03

STANDARD

Submissions Property Types

ORIG

1

Null

31

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
        )

)