NDA 022462

PIRAMAL CRITICAL

FDA Drug Application

Application #022462

Documents

• Letter: 2015-02-12
• Label: 2010-11-26
• Review: 2011-03-07
• Summary Review: 2011-03-07
• Letter: 2010-11-29
• Label: 2015-02-12
• Review: 2019-02-01
• Letter: 2019-12-23
• Label: 2019-12-23
• Letter: 2021-04-20
• Letter: 2022-06-01
• Label: 2022-06-01

Application Sponsors

NDA 022462

PIRAMAL CRITICAL

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	INJECTABLE;INTRATHECAL	0.05MG/ML	0	GABLOFEN	BACLOFEN
002	INJECTABLE;INTRATHECAL	0.5MG/ML	0	GABLOFEN	BACLOFEN
003	INJECTABLE;INTRATHECAL	2MG/ML	0	GABLOFEN	BACLOFEN
004	INJECTABLE;INTRATHECAL	1MG/ML	1	GABLOFEN	BACLOFEN

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2010-11-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2012-06-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2013-01-17	STANDARD
LABELING; Labeling	SUPPL	8	AP	2015-02-11	STANDARD
LABELING; Labeling	SUPPL	11	AP	2019-12-19	STANDARD
LABELING; Labeling	SUPPL	13	TA	2020-10-23	STANDARD
LABELING; Labeling	SUPPL	15	AP	2021-12-02	STANDARD

Submissions Property Types

ORIG	1	Null	40
SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	8	Null	15
SUPPL	11	Null	7
SUPPL	13	Null	15
SUPPL	15	Null	15

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP
004	Prescription	AP

CDER Filings

PIRAMAL CRITICAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22462
            [companyName] => PIRAMAL CRITICAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"GABLOFEN","activeIngredients":"BACLOFEN","strength":"0.05MG\/ML","dosageForm":"INJECTABLE;INTRATHECAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"GABLOFEN","activeIngredients":"BACLOFEN","strength":"0.5MG\/ML","dosageForm":"INJECTABLE;INTRATHECAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"GABLOFEN","activeIngredients":"BACLOFEN","strength":"2MG\/ML","dosageForm":"INJECTABLE;INTRATHECAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"GABLOFEN","activeIngredients":"BACLOFEN","strength":"1MG\/ML","dosageForm":"INJECTABLE;INTRATHECAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"12\/19\/2019","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022462s011lbl.pdf\"}]","notes":""},{"actionDate":"02\/11\/2015","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022462s008lbl.pdf\"}]","notes":""},{"actionDate":"11\/19\/2010","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022462s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"GABLOFEN","submission":"BACLOFEN","actionType":"0.05MG\/ML","submissionClassification":"INJECTABLE;INTRATHECAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"GABLOFEN","submission":"BACLOFEN","actionType":"0.5MG\/ML","submissionClassification":"INJECTABLE;INTRATHECAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"GABLOFEN","submission":"BACLOFEN","actionType":"2MG\/ML","submissionClassification":"INJECTABLE;INTRATHECAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"GABLOFEN","submission":"BACLOFEN","actionType":"1MG\/ML","submissionClassification":"INJECTABLE;INTRATHECAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-12-19
        )

)