PRINSTON PHARMA INC FDA Approval ANDA 207883

ANDA 207883

PRINSTON PHARMA INC

FDA Drug Application

Application #207883

Application Sponsors

ANDA 207883PRINSTON PHARMA INC

Marketing Status

None (Tentative Approval)001
None (Tentative Approval)002
None (Tentative Approval)003
None (Tentative Approval)004
None (Tentative Approval)005
None (Tentative Approval)006
None (Tentative Approval)007
None (Tentative Approval)008

Application Products

001CAPSULE;ORAL25MG0PREGABALINPREGABALIN
002CAPSULE;ORAL50MG0PREGABALINPREGABALIN
003CAPSULE;ORAL75MG0PREGABALINPREGABALIN
004CAPSULE;ORAL100MG0PREGABALINPREGABALIN
005CAPSULE;ORAL150MG0PREGABALINPREGABALIN
006CAPSULE;ORAL200MG0PREGABALINPREGABALIN
007CAPSULE;ORAL225MG0PREGABALINPREGABALIN
008CAPSULE;ORAL300MG0PREGABALINPREGABALIN

FDA Submissions

UNKNOWN; ORIG1TA2017-12-07STANDARD

Submissions Property Types

ORIG1Null31

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB
005PrescriptionAB
006PrescriptionAB
007PrescriptionAB
008PrescriptionAB

CDER Filings

PRINSTON PHARMA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207883
            [companyName] => PRINSTON PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PREGABALIN","activeIngredients":"PREGABALIN","strength":"25MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"PREGABALIN","activeIngredients":"PREGABALIN","strength":"50MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"PREGABALIN","activeIngredients":"PREGABALIN","strength":"75MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"PREGABALIN","activeIngredients":"PREGABALIN","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"PREGABALIN","activeIngredients":"PREGABALIN","strength":"150MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"PREGABALIN","activeIngredients":"PREGABALIN","strength":"200MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"PREGABALIN","activeIngredients":"PREGABALIN","strength":"225MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"PREGABALIN","activeIngredients":"PREGABALIN","strength":"300MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/07\/2017","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-12-07
        )

)

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