ANDA 212432

PIRAMAL HLTHCARE UK

FDA Drug Application

Application #212432

Application Sponsors

ANDA 212432

PIRAMAL HLTHCARE UK

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	EQ 2MG BASE/ML	0	CISATRACURIUM BESYLATE	CISATRACURIUM BESYLATE
002	INJECTABLE;INJECTION	EQ 10MG BASE/ML	0	CISATRACURIUM BESYLATE	CISATRACURIUM BESYLATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-03-11

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

PIRAMAL HLTHCARE UK

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212432
            [companyName] => PIRAMAL HLTHCARE UK
            [docInserts] => ["",""]
            [products] => [{"drugName":"CISATRACURIUM BESYLATE","activeIngredients":"CISATRACURIUM BESYLATE","strength":"EQ 2MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CISATRACURIUM BESYLATE","activeIngredients":"CISATRACURIUM BESYLATE","strength":"EQ 10MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CISATRACURIUM BESYLATE","submission":"CISATRACURIUM BESYLATE","actionType":"EQ 2MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CISATRACURIUM BESYLATE","submission":"CISATRACURIUM BESYLATE","actionType":"EQ 10MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)