HETERO LABS LTD III FDA Approval ANDA 206912

ANDA 206912

HETERO LABS LTD III

FDA Drug Application

Application #206912

Application Sponsors

ANDA 206912HETERO LABS LTD III

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005
Prescription006
Prescription007
Prescription008

Application Products

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

FDA Submissions

UNKNOWN; ORIG1AP2019-10-08STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

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

CDER Filings

HETERO LABS LTD III
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206912
            [companyName] => HETERO LABS LTD III
            [docInserts] => ["",""]
            [products] => [{"drugName":"PREGABALIN","activeIngredients":"PREGABALIN","strength":"25MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PREGABALIN","activeIngredients":"PREGABALIN","strength":"50MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PREGABALIN","activeIngredients":"PREGABALIN","strength":"75MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PREGABALIN","activeIngredients":"PREGABALIN","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PREGABALIN","activeIngredients":"PREGABALIN","strength":"150MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PREGABALIN","activeIngredients":"PREGABALIN","strength":"200MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PREGABALIN","activeIngredients":"PREGABALIN","strength":"225MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PREGABALIN","activeIngredients":"PREGABALIN","strength":"300MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/08\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-10-08
        )

)

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