NDA 010721

CASPER PHARMA LLC

FDA Drug Application

Application #010721

Documents

• Letter: 2012-10-24
• Label: 2012-10-24
• Label: 2018-04-16
• Letter: 2018-04-16
• Label: 2018-12-13
• Letter: 2018-12-20
• Label: 2019-06-03
• Letter: 2019-07-01
• Label: 2019-07-05

Application Sponsors

NDA 010721

CASPER PHARMA LLC

Marketing Status

• Prescription: 001
• Prescription: 004
• Prescription: 005
• Prescription: 006

Application Products

001	TABLET;ORAL	50MG	1	ANTIVERT	MECLIZINE HYDROCHLORIDE
004	TABLET;ORAL	25MG	1	ANTIVERT	MECLIZINE HYDROCHLORIDE
005	TABLET, CHEWABLE;ORAL	25MG	1	ANTIVERT	MECLIZINE HYDROCHLORIDE
006	TABLET;ORAL	12.5MG	1	ANTIVERT	MECLIZINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	1957-02-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	50	AP	1993-03-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	51	AP	1993-09-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	52	AP	1993-09-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	53	AP	1999-11-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	54	AP	1999-12-14	STANDARD
LABELING; Labeling	SUPPL	58	AP	2012-10-23	STANDARD
EFFICACY; Efficacy	SUPPL	61	AP	2018-04-13	STANDARD
LABELING; Labeling	SUPPL	62	AP	2018-12-12	STANDARD
EFFICACY; Efficacy	SUPPL	63	AP	2019-06-28	STANDARD

Submissions Property Types

SUPPL	50	Null	0
SUPPL	51	Null	0
SUPPL	52	Null	0
SUPPL	53	Null	0
SUPPL	54	Null	0
SUPPL	58	Null	15
SUPPL	61	Null	7
SUPPL	62	Null	15
SUPPL	63	Null	6

TE Codes

001	Prescription	AA
004	Prescription	AA
005	Prescription	AA
006	Prescription	AA

CDER Filings

CASPER PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 10721
            [companyName] => CASPER PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ANTIVERT","activeIngredients":"MECLIZINE HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"ANTIVERT","activeIngredients":"MECLIZINE HYDROCHLORIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"ANTIVERT","activeIngredients":"MECLIZINE HYDROCHLORIDE","strength":"25MG","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"ANTIVERT","activeIngredients":"MECLIZINE HYDROCHLORIDE","strength":"12.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"06\/28\/2019","submission":"SUPPL-63","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/010721s063lbl.pdf\"}]","notes":""},{"actionDate":"12\/12\/2018","submission":"SUPPL-62","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/010721Orig1s062_CartonLbl.pdf\"}]","notes":""},{"actionDate":"12\/12\/2018","submission":"SUPPL-62","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/017210s062lbl.pdf\"}]","notes":""},{"actionDate":"04\/13\/2018","submission":"SUPPL-61","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/010721s061lbl.pdf\"}]","notes":""},{"actionDate":"10\/23\/2012","submission":"SUPPL-58","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/010721s058lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ANTIVERT","submission":"MECLIZINE HYDROCHLORIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ANTIVERT","submission":"MECLIZINE HYDROCHLORIDE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ANTIVERT","submission":"MECLIZINE HYDROCHLORIDE","actionType":"25MG","submissionClassification":"TABLET, CHEWABLE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ANTIVERT","submission":"MECLIZINE HYDROCHLORIDE","actionType":"12.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-06-28
        )

)