ANDA 076150

INTL MEDICATION SYS

FDA Drug Application

Application #076150

Application Sponsors

ANDA 076150

INTL MEDICATION SYS

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

2MG/ML

0

LORAZEPAM

LORAZEPAM

FDA Submissions

	ORIG	1	AP	2004-11-15
LABELING; Labeling	SUPPL	3	AP	2020-06-05	STANDARD
LABELING; Labeling	SUPPL	5	AP	2022-08-09	STANDARD

Submissions Property Types

SUPPL	1	Null	15
SUPPL	3	Null	7
SUPPL	5	Null	15

TE Codes

001

Prescription

AP

CDER Filings

INTL MEDICATION SYS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76150
            [companyName] => INTL MEDICATION SYS
            [docInserts] => ["",""]
            [products] => [{"drugName":"LORAZEPAM","activeIngredients":"LORAZEPAM","strength":"2MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LORAZEPAM","submission":"LORAZEPAM","actionType":"2MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)