ANDA 212025

SAGE CHEMS

FDA Drug Application

Application #212025

Documents

• Letter: 2022-08-09

Application Sponsors

ANDA 212025

SAGE CHEMS

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;SUBCUTANEOUS

30MG/3ML (10MG/ML)

0

APOMORPHINE HYDROCHLORIDE

APOMORPHINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-02-23

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

SAGE CHEMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212025
            [companyName] => SAGE CHEMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"APOMORPHINE HYDROCHLORIDE","activeIngredients":"APOMORPHINE HYDROCHLORIDE","strength":"30MG\/3ML (10MG\/ML)","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/23\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-02-23
        )

)