ANDA 077867

PIRAMAL CRITICAL

FDA Drug Application

Application #077867

Application Sponsors

ANDA 077867

PIRAMAL CRITICAL

Marketing Status

• Prescription: 001

Application Products

001

LIQUID;INHALATION

100%

0

SOJOURN

SEVOFLURANE

FDA Submissions

	ORIG	1	AP	2007-05-02
LABELING; Labeling	SUPPL	4	AP	2011-03-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2012-01-20
LABELING; Labeling	SUPPL	8	AP	2012-01-31
LABELING; Labeling	SUPPL	9	AP	2015-09-16	STANDARD
LABELING; Labeling	SUPPL	11	AP	2015-09-16	STANDARD
LABELING; Labeling	SUPPL	12	AP	2015-09-16	STANDARD
LABELING; Labeling	SUPPL	18	AP	2020-03-25	STANDARD

Submissions Property Types

SUPPL	7	Null	15
SUPPL	8	Null	15
SUPPL	9	Null	15
SUPPL	11	Null	15
SUPPL	12	Null	15
SUPPL	18	Null	7

TE Codes

001

Prescription

AN

CDER Filings

PIRAMAL CRITICAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77867
            [companyName] => PIRAMAL CRITICAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"SOJOURN","activeIngredients":"SEVOFLURANE","strength":"100%","dosageForm":"LIQUID;INHALATION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"SOJOURN","submission":"SEVOFLURANE","actionType":"100%","submissionClassification":"LIQUID;INHALATION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)