STRIDES PHARMA FDA Approval ANDA 212635

ANDA 212635

STRIDES PHARMA

FDA Drug Application

Application #212635

Application Sponsors

ANDA 212635STRIDES PHARMA

Marketing Status

Prescription001
Prescription002

Application Products

001CAPSULE;ORAL250MG0TETRACYCLINE HYDROCHLORIDETETRACYCLINE HYDROCHLORIDE
002CAPSULE;ORAL500MG0TETRACYCLINE HYDROCHLORIDETETRACYCLINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-03-03STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

STRIDES PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212635
            [companyName] => STRIDES PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"TETRACYCLINE HYDROCHLORIDE","activeIngredients":"TETRACYCLINE HYDROCHLORIDE","strength":"250MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TETRACYCLINE HYDROCHLORIDE","activeIngredients":"TETRACYCLINE HYDROCHLORIDE","strength":"500MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/03\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-03-03
        )

)

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