ANDA 210830

AMNEAL PHARMS LLC

FDA Drug Application

Application #210830

Documents

• Letter: 2020-03-23
• Review: 2023-01-13

Application Sponsors

ANDA 210830

AMNEAL PHARMS LLC

Marketing Status

• Prescription: 001

Application Products

001

RING;VAGINAL

0.015MG/24HR;0.12MG/24HR

0

ELURYNG

ETHINYL ESTRADIOL; ETONOGESTREL

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-12-11

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AB

CDER Filings

AMNEAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210830
            [companyName] => AMNEAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"ELURYNG","activeIngredients":"ETHINYL ESTRADIOL; ETONOGESTREL","strength":"0.015MG\/24HR;0.12MG\/24HR","dosageForm":"RING;VAGINAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/11\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/210830Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-12-11
        )

)