ANDA 212868

ACCORD HLTHCARE

FDA Drug Application

Application #212868

Documents

• Letter: 2021-08-16

Application Sponsors

ANDA 212868

ACCORD HLTHCARE

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	SOLUTION;INTRAVENOUS	0.25MG/5ML (0.5MG/ML)	0	ATROPINE SULFATE	ATROPINE SULFATE
002	SOLUTION;INTRAVENOUS	0.5MG/5ML (0.1MG/ML)	0	ATROPINE SULFATE	ATROPINE SULFATE
003	SOLUTION;INTRAVENOUS	1MG/10ML (0.1MG/ML)	0	ATROPINE SULFATE	ATROPINE SULFATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2021-07-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2022-11-23	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP

CDER Filings

ACCORD HLTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212868
            [companyName] => ACCORD HLTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"ATROPINE SULFATE","activeIngredients":"ATROPINE SULFATE","strength":"0.25MG\/5ML (0.5MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ATROPINE SULFATE","activeIngredients":"ATROPINE SULFATE","strength":"0.5MG\/5ML (0.1MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ATROPINE SULFATE","activeIngredients":"ATROPINE SULFATE","strength":"1MG\/10ML (0.1MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/26\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-07-26
        )

)