NDA 016812

PAR STERILE PRODUCTS

FDA Drug Application

Application #016812

Documents

• Letter: 2003-07-31
• Letter: 2012-03-13
• Label: 2012-03-09
• Letter: 2017-05-02
• Label: 2017-05-02
• Label: 2018-08-09
• Label: 2020-08-25
• Letter: 2020-08-25
• Letter: 2022-06-06
• Label: 2022-06-08
• Letter: 2022-09-08

Application Sponsors

NDA 016812

PAR STERILE PRODUCTS

Marketing Status

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

Application Products

001	INJECTABLE;INJECTION	EQ 10MG BASE/ML	1	KETALAR	KETAMINE HYDROCHLORIDE
002	INJECTABLE;INJECTION	EQ 50MG BASE/ML	1	KETALAR	KETAMINE HYDROCHLORIDE
003	INJECTABLE;INJECTION	EQ 100MG BASE/ML	1	KETALAR	KETAMINE HYDROCHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1970-02-19	PRIORITY
LABELING; Labeling	SUPPL	14	AP	1976-05-14
LABELING; Labeling	SUPPL	15	AP	1977-01-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1977-05-16	PRIORITY
LABELING; Labeling	SUPPL	18	AP	1977-05-16
LABELING; Labeling	SUPPL	19	AP	1977-07-05
LABELING; Labeling	SUPPL	20	AP	1980-04-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1980-04-04	PRIORITY
LABELING; Labeling	SUPPL	22	AP	1980-08-18
EFFICACY; Efficacy	SUPPL	23	AP	1982-06-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1989-02-07	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1994-11-29	PRIORITY
LABELING; Labeling	SUPPL	26	AP	2001-02-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1997-09-05	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1998-11-17	PRIORITY
LABELING; Labeling	SUPPL	29	AP	2000-03-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	2000-03-29	PRIORITY
LABELING; Labeling	SUPPL	32	AP	2002-11-14	STANDARD
LABELING; Labeling	SUPPL	39	AP	2012-03-07	UNKNOWN
LABELING; Labeling	SUPPL	40	AP	2018-08-07	STANDARD
LABELING; Labeling	SUPPL	43	AP	2017-04-27	STANDARD
LABELING; Labeling	SUPPL	46	AP	2020-08-24	STANDARD
LABELING; Labeling	SUPPL	51	AP	2022-06-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	52	AP	2022-08-23	N/A

Submissions Property Types

SUPPL	17	Null	0
SUPPL	21	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	27	Null	0
SUPPL	28	Null	0
SUPPL	30	Null	0
SUPPL	39	Null	7
SUPPL	40	Null	7
SUPPL	43	Null	6
SUPPL	46	Null	7
SUPPL	51	Null	7

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP

CDER Filings

PAR STERILE PRODUCTS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 16812
            [companyName] => PAR STERILE PRODUCTS
            [docInserts] => ["",""]
            [products] => [{"drugName":"KETALAR","activeIngredients":"KETAMINE HYDROCHLORIDE","strength":"EQ 10MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"KETALAR","activeIngredients":"KETAMINE HYDROCHLORIDE","strength":"EQ 50MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"KETALAR","activeIngredients":"KETAMINE HYDROCHLORIDE","strength":"EQ 100MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"08\/24\/2020","submission":"SUPPL-46","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/016812s046lbl.pdf\"}]","notes":""},{"actionDate":"08\/07\/2018","submission":"SUPPL-40","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/016812s040lbl.pdf\"}]","notes":""},{"actionDate":"04\/27\/2017","submission":"SUPPL-43","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/016812s043lbl.pdf\"}]","notes":""},{"actionDate":"03\/07\/2012","submission":"SUPPL-39","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/016812s039lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"KETALAR","submission":"KETAMINE HYDROCHLORIDE","actionType":"EQ 10MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"KETALAR","submission":"KETAMINE HYDROCHLORIDE","actionType":"EQ 50MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"KETALAR","submission":"KETAMINE HYDROCHLORIDE","actionType":"EQ 100MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-08-24
        )

)