NDA 022544

ALMATICA

FDA Drug Application

Application #022544

Documents

• Letter: 2011-02-03
• Letter: 2011-07-05
• Letter: 2012-08-10
• Label: 2012-02-01
• Label: 2013-04-01
• Review: 2011-10-18
• Medication Guide: 2011-03-01
• Letter: 2011-05-03
• Letter: 2012-02-03
• Label: 2011-02-04
• Label: 2011-06-30
• Label: 2012-08-09
• Summary Review: 2011-10-18
• Letter: 2020-04-03
• Label: 2020-04-10
• Letter: 2021-10-08
• Label: 2021-10-08
• Review: 2022-10-19

Application Sponsors

NDA 022544

ALMATICA

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	300MG	1	GRALISE	GABAPENTIN
002	TABLET;ORAL	600MG	1	GRALISE	GABAPENTIN

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2011-01-28	STANDARD
LABELING; Labeling	SUPPL	2	AP	2011-06-28	STANDARD
REMS; REMS	SUPPL	3	AP	2011-04-28	N/A
LABELING; Labeling	SUPPL	6	AP	2012-01-31	STANDARD
LABELING; Labeling	SUPPL	8	AP	2012-08-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2012-11-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2013-03-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2013-01-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2013-03-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2013-02-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2013-03-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2013-04-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2013-07-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2013-06-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2013-09-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	2017-01-09	STANDARD
LABELING; Labeling	SUPPL	24	AP	2017-03-06	STANDARD
LABELING; Labeling	SUPPL	26	AP	2020-04-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	2021-09-16	N/A

Submissions Property Types

ORIG	1	Null	6
SUPPL	2	Null	6
SUPPL	3	Null	6
SUPPL	6	Null	7
SUPPL	8	Null	6
SUPPL	10	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	24	Null	15
SUPPL	26	Null	15

TE Codes

001	Prescription	BX
002	Prescription	BX

CDER Filings

ALMATICA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22544
            [companyName] => ALMATICA
            [docInserts] => ["Medication Guide","http:\/\/www.fda.gov\/downloads\/Drugs\/DrugSafety\/UCM245196.pdf"]
            [products] => [{"drugName":"GRALISE","activeIngredients":"GABAPENTIN","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"GRALISE","activeIngredients":"GABAPENTIN","strength":"600MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"04\/02\/2020","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/022544s026lbl.pdf\"}]","notes":""},{"actionDate":"03\/27\/2013","submission":"SUPPL-12","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022544s012lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"08\/08\/2012","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022544s008lbl.pdf\"}]","notes":""},{"actionDate":"01\/31\/2012","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022544s006lbl.pdf\"}]","notes":""},{"actionDate":"06\/28\/2011","submission":"SUPPL-2","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022544s002lbl.pdf\"}]","notes":""},{"actionDate":"01\/28\/2011","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022544s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"GRALISE","submission":"GABAPENTIN","actionType":"300MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"GRALISE","submission":"GABAPENTIN","actionType":"600MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-04-02
        )

)