US GENERICS, STERILES FDA Approval ANDA 208038

ANDA 208038

US GENERICS, STERILES

FDA Drug Application

Application #208038

Documents

Letter2021-09-02

Application Sponsors

ANDA 208038US GENERICS, STERILES

Marketing Status

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

Application Products

001SOLUTION;SUBCUTANEOUS12MG/0.6ML0METHYLNALTREXONE BROMIDEMETHYLNALTREXONE BROMIDE

FDA Submissions

UNKNOWN; ORIG1TA2021-08-12STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

US GENERICS, STERILES
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            [companyName] => US GENERICS, STERILES
            [docInserts] => ["",""]
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            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/12\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/208038Orig1s000TA_ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-08-12
        )

)

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