ANDA 075494

AKORN INC

FDA Drug Application

Application #075494

Documents

• Letter: 2000-06-30

Application Sponsors

ANDA 075494

AKORN INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	EQ 1MG BASE/ML	0	MIDAZOLAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE
002	INJECTABLE;INJECTION	EQ 5MG BASE/ML	0	MIDAZOLAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2000-06-30
LABELING; Labeling	SUPPL	2	AP	2012-11-01	STANDARD
LABELING; Labeling	SUPPL	3	AP	2017-04-27	STANDARD

Submissions Property Types

SUPPL	2	Null	15
SUPPL	3	Null	7

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

AKORN INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75494
            [companyName] => AKORN INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MIDAZOLAM HYDROCHLORIDE","activeIngredients":"MIDAZOLAM HYDROCHLORIDE","strength":"EQ 1MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MIDAZOLAM HYDROCHLORIDE","activeIngredients":"MIDAZOLAM HYDROCHLORIDE","strength":"EQ 5MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MIDAZOLAM HYDROCHLORIDE","submission":"MIDAZOLAM HYDROCHLORIDE","actionType":"EQ 1MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"MIDAZOLAM HYDROCHLORIDE","submission":"MIDAZOLAM HYDROCHLORIDE","actionType":"EQ 5MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)