ANNORA PHARMA FDA Approval ANDA 216446

ANDA 216446

ANNORA PHARMA

FDA Drug Application

Application #216446

Application Sponsors

ANDA 216446ANNORA PHARMA

Marketing Status

Prescription001
Prescription002

Application Products

001SUPPOSITORY;RECTAL12.5MG0PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDE
002SUPPOSITORY;RECTAL25MG0PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2022-11-02STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

ANNORA PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216446
            [companyName] => ANNORA PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROMETHAZINE HYDROCHLORIDE","activeIngredients":"PROMETHAZINE HYDROCHLORIDE","strength":"12.5MG","dosageForm":"SUPPOSITORY;RECTAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PROMETHAZINE HYDROCHLORIDE","activeIngredients":"PROMETHAZINE HYDROCHLORIDE","strength":"25MG","dosageForm":"SUPPOSITORY;RECTAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/02\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-11-02
        )

)

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