NDA 012366

MEDA PHARMS

FDA Drug Application

Application #012366

Documents

• Label: 2008-11-07
• Label: 2009-11-16
• Label: 2013-02-01
• Label: 2013-05-14
• Letter: 2008-10-28
• Letter: 2010-01-06
• Letter: 2013-02-04
• Letter: 2013-05-13

Application Sponsors

NDA 012366

MEDA PHARMS

Marketing Status

• Discontinued: 002

Application Products

002

TABLET;ORAL

325MG;200MG;16MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

0

SOMA COMPOUND W/ CODEINE

ASPIRIN; CARISOPRODOL; CODEINE PHOSPHATE

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	1960-10-05	STANDARD
LABELING; Labeling	SUPPL	6	AP	1974-07-19	STANDARD
LABELING; Labeling	SUPPL	9	AP	1981-11-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1981-11-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1981-10-29	STANDARD
LABELING; Labeling	SUPPL	13	AP	1982-02-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1983-04-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1983-04-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1983-04-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1983-07-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1984-02-23	STANDARD
LABELING; Labeling	SUPPL	21	AP	1986-01-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1993-10-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1998-04-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	2001-06-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	2000-03-02	STANDARD
LABELING; Labeling	SUPPL	31	AP	2008-10-23	STANDARD
LABELING; Labeling	SUPPL	32	AP	2009-11-06	STANDARD
LABELING; Labeling	SUPPL	33	AP	2013-01-31	STANDARD
LABELING; Labeling	SUPPL	34	AP	2013-05-09	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	6	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	21	Null	0
SUPPL	25	Null	0
SUPPL	26	Null	0
SUPPL	28	Null	0
SUPPL	29	Null	0
SUPPL	31	Null	0
SUPPL	32	Null	0
SUPPL	33	Null	0
SUPPL	34	Null	0

CDER Filings

MEDA PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 12366
            [companyName] => MEDA PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"SOMA COMPOUND W\/ CODEINE","activeIngredients":"ASPIRIN; CARISOPRODOL; CODEINE PHOSPHATE","strength":"325MG;200MG;16MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"05\/09\/2013","submission":"SUPPL-34","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/012366s034lbl.pdf\"}]","notes":""},{"actionDate":"01\/31\/2013","submission":"SUPPL-33","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/012366s033lbl.pdf\"}]","notes":""},{"actionDate":"11\/06\/2009","submission":"SUPPL-32","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/012366s032lbl.pdf\"}]","notes":""},{"actionDate":"10\/23\/2008","submission":"SUPPL-31","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/012366s031lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"SOMA COMPOUND W\/ CODEINE","submission":"ASPIRIN; CARISOPRODOL; CODEINE PHOSPHATE","actionType":"325MG;200MG;16MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2013-05-09
        )

)