ANDA 215516

PIRAMAL CRITICAL

FDA Drug Application

Application #215516

Application Sponsors

ANDA 215516

PIRAMAL CRITICAL

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

2022-05-24

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

PIRAMAL CRITICAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215516
            [companyName] => PIRAMAL CRITICAL
            [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":"05\/24\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-05-24
        )

)