UNIQUE PHARM LABS FDA Approval ANDA 207613

ANDA 207613

UNIQUE PHARM LABS

FDA Drug Application

Application #207613

Application Sponsors

ANDA 207613UNIQUE PHARM LABS

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL2.5MG0MIDODRINE HYDROCHLORIDEMIDODRINE HYDROCHLORIDE
002TABLET;ORAL5MG0MIDODRINE HYDROCHLORIDEMIDODRINE HYDROCHLORIDE
003TABLET;ORAL10MG0MIDODRINE HYDROCHLORIDEMIDODRINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2018-11-02STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

UNIQUE PHARM LABS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207613
            [companyName] => UNIQUE PHARM LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"MIDODRINE HYDROCHLORIDE","activeIngredients":"MIDODRINE HYDROCHLORIDE","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MIDODRINE HYDROCHLORIDE","activeIngredients":"MIDODRINE HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MIDODRINE HYDROCHLORIDE","activeIngredients":"MIDODRINE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/02\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-11-02
        )

)

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