NDA 012365

MEDA PHARMS

FDA Drug Application

Application #012365

Documents

• Letter: 2010-01-06
• Letter: 2013-02-04
• Label: 2013-02-01
• Letter: 2009-04-03
• Label: 2009-04-03
• Label: 2009-11-17

Application Sponsors

NDA 012365

MEDA PHARMS

Marketing Status

• Discontinued: 005

Application Products

005

TABLET;ORAL

325MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

0

SOMA COMPOUND

ASPIRIN; CARISOPRODOL

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	1960-09-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1974-12-12	STANDARD
LABELING; Labeling	SUPPL	13	AP	1974-07-19
LABELING; Labeling	SUPPL	14	AP	1974-12-12
LABELING; Labeling	SUPPL	20	AP	1980-02-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1981-10-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1983-03-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1983-04-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1983-04-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1983-04-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1983-07-11	STANDARD
LABELING; Labeling	SUPPL	30	AP	1986-01-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	1986-09-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	1993-10-25	STANDARD
LABELING; Labeling	SUPPL	35	AP	2009-04-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	2000-03-02	STANDARD
LABELING; Labeling	SUPPL	38	AP	2009-11-17	UNKNOWN
LABELING; Labeling	SUPPL	39	AP	2013-01-31	STANDARD

Submissions Property Types

SUPPL	12	Null	0
SUPPL	22	Null	0
SUPPL	24	Null	0
SUPPL	26	Null	0
SUPPL	27	Null	0
SUPPL	28	Null	0
SUPPL	29	Null	0
SUPPL	31	Null	0
SUPPL	33	Null	0
SUPPL	36	Null	0
SUPPL	38	Null	31
SUPPL	39	Null	6

CDER Filings

MEDA PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 12365
            [companyName] => MEDA PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"SOMA COMPOUND","activeIngredients":"ASPIRIN; CARISOPRODOL","strength":"325MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]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":"01\/31\/2013","submission":"SUPPL-39","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/012365s039lbl.pdf\"}]","notes":""},{"actionDate":"11\/17\/2009","submission":"SUPPL-38","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/012365s038lbl.pdf\"}]","notes":""},{"actionDate":"04\/01\/2009","submission":"SUPPL-35","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/012365s035lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"SOMA COMPOUND","submission":"ASPIRIN; CARISOPRODOL","actionType":"325MG;200MG **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] => 2013-01-31
        )

)