ANDA 211328

MAYNE PHARMA

FDA Drug Application

Application #211328

Application Sponsors

ANDA 211328

MAYNE PHARMA

Marketing Status

• Prescription: 001

Application Products

001

RING;VAGINAL

0.015MG/24HR;0.12MG/24HR

0

HALOETTE

ETHINYL ESTRADIOL; ETONOGESTREL

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-08-05

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

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
        )

)