MAYNE PHARMA FDA Approval ANDA 211328

ANDA 211328

MAYNE PHARMA

FDA Drug Application

Application #211328

Application Sponsors

ANDA 211328MAYNE PHARMA

Marketing Status

Prescription001

Application Products

001RING;VAGINAL0.015MG/24HR;0.12MG/24HR0HALOETTEETHINYL ESTRADIOL; ETONOGESTREL

FDA Submissions

UNKNOWN; ORIG1AP2022-08-05STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

CDER Filings

MAYNE PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211328
            [companyName] => MAYNE PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"HALOETTE","activeIngredients":"ETHINYL ESTRADIOL; ETONOGESTREL","strength":"0.015MG\/24HR;0.12MG\/24HR","dosageForm":"RING;VAGINAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/05\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-08-05
        )

)

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