ANDA 216120

AM REGENT

FDA Drug Application

Application #216120

Documents

• Letter: 2022-08-25

Application Sponsors

ANDA 216120

AM REGENT

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	SOLUTION;INTRAVENOUS	0.4MG/ML (0.4MG/ML)	0	ATROPINE SULFATE	ATROPINE SULFATE
002	SOLUTION;INTRAVENOUS	1MG/ML (1MG/ML)	0	ATROPINE SULFATE	ATROPINE SULFATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-05-26

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

AM REGENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216120
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"ATROPINE SULFATE","activeIngredients":"ATROPINE SULFATE","strength":"0.4MG\/ML (0.4MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ATROPINE SULFATE","activeIngredients":"ATROPINE SULFATE","strength":"1MG\/ML (1MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/26\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-05-26
        )

)