NOSTRUM LABS INC FDA Approval ANDA 209393

ANDA 209393

NOSTRUM LABS INC

FDA Drug Application

Application #209393

Application Sponsors

ANDA 209393NOSTRUM LABS INC

Marketing Status

Prescription001
Prescription002

Application Products

001CAPSULE;ORALEQ 50MG BASE0DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATE
002CAPSULE;ORALEQ 100MG BASE0DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATE

FDA Submissions

UNKNOWN; ORIG1AP2020-12-10STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

NOSTRUM LABS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209393
            [companyName] => NOSTRUM LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOXYCYCLINE HYCLATE","activeIngredients":"DOXYCYCLINE HYCLATE","strength":"EQ 50MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOXYCYCLINE HYCLATE","activeIngredients":"DOXYCYCLINE HYCLATE","strength":"EQ 100MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/10\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-12-10
        )

)

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