ANDA 075637

BAXTER HLTHCARE CORP

FDA Drug Application

Application #075637

Documents

• Letter: 2000-10-31

Application Sponsors

ANDA 075637

BAXTER HLTHCARE CORP

Marketing Status

• Discontinued: 001
• Discontinued: 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	2000-10-31
LABELING; Labeling	SUPPL	12	AP	2017-04-27	STANDARD
LABELING; Labeling	SUPPL	13	AP	2017-04-27	STANDARD
LABELING; Labeling	SUPPL	17	AP	2023-01-17	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	12	Null	7
SUPPL	13	Null	15
SUPPL	17	Null	7

CDER Filings

BAXTER HLTHCARE CORP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75637
            [companyName] => BAXTER HLTHCARE CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"MIDAZOLAM HYDROCHLORIDE","activeIngredients":"MIDAZOLAM HYDROCHLORIDE","strength":"EQ 1MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"MIDAZOLAM HYDROCHLORIDE","activeIngredients":"MIDAZOLAM HYDROCHLORIDE","strength":"EQ 5MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MIDAZOLAM HYDROCHLORIDE","submission":"MIDAZOLAM HYDROCHLORIDE","actionType":"EQ 1MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"MIDAZOLAM HYDROCHLORIDE","submission":"MIDAZOLAM HYDROCHLORIDE","actionType":"EQ 5MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)