ANDA 076092

MYLAN INSTITUTIONAL

FDA Drug Application

Application #076092

Documents

• Letter: 2003-04-16
• Review: 2006-04-20

Application Sponsors

ANDA 076092

MYLAN INSTITUTIONAL

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	INJECTABLE;INJECTION	EQ 10MG BASE/ML	0	KETAMINE HYDROCHLORIDE	KETAMINE HYDROCHLORIDE
002	INJECTABLE;INJECTION	EQ 50MG BASE/ML	0	KETAMINE HYDROCHLORIDE	KETAMINE HYDROCHLORIDE
003	INJECTABLE;INJECTION	EQ 100MG BASE/ML	0	KETAMINE HYDROCHLORIDE	KETAMINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2001-12-28
LABELING; Labeling	SUPPL	2	AP	2002-10-25
LABELING; Labeling	SUPPL	9	AP	2008-09-30
LABELING; Labeling	SUPPL	18	AP	2012-10-05	STANDARD
LABELING; Labeling	SUPPL	23	AP	2018-12-31	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	18	Null	15
SUPPL	23	Null	7

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP

CDER Filings

MYLAN INSTITUTIONAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76092
            [companyName] => MYLAN INSTITUTIONAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"KETAMINE HYDROCHLORIDE","activeIngredients":"KETAMINE HYDROCHLORIDE","strength":"EQ 10MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"KETAMINE HYDROCHLORIDE","activeIngredients":"KETAMINE HYDROCHLORIDE","strength":"EQ 50MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"KETAMINE HYDROCHLORIDE","activeIngredients":"KETAMINE HYDROCHLORIDE","strength":"EQ 100MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"KETAMINE HYDROCHLORIDE","submission":"KETAMINE HYDROCHLORIDE","actionType":"EQ 10MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"KETAMINE HYDROCHLORIDE","submission":"KETAMINE HYDROCHLORIDE","actionType":"EQ 50MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"KETAMINE HYDROCHLORIDE","submission":"KETAMINE HYDROCHLORIDE","actionType":"EQ 100MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)