NDA 019856

MERCK SHARP DOHME

FDA Drug Application

Application #019856

Documents

• Letter: 2011-02-07
• Letter: 2014-07-23
• Label: 2009-01-06
• Label: 2014-07-22
• Letter: 2014-07-23
• Letter: 2014-07-23
• Letter: 2009-01-06
• Label: 2014-07-22
• Label: 2014-07-22
• Label: 2011-02-04

Application Sponsors

NDA 019856

MERCK SHARP DOHME

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	50MG;200MG	1	SINEMET CR	CARBIDOPA; LEVODOPA
002	TABLET, EXTENDED RELEASE;ORAL	25MG;100MG	1	SINEMET CR	CARBIDOPA; LEVODOPA

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1991-05-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1992-12-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1993-10-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1996-05-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1996-05-07	STANDARD
LABELING; Labeling	SUPPL	6	AP	1999-05-10	STANDARD
LABELING; Labeling	SUPPL	7	AP	1999-05-10	STANDARD
LABELING; Labeling	SUPPL	9	AP	1999-05-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1998-06-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1999-08-04	STANDARD
LABELING; Labeling	SUPPL	12	AP	1999-05-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2000-06-06	STANDARD
LABELING; Labeling	SUPPL	15	AP	2000-05-02	STANDARD
LABELING; Labeling	SUPPL	16	AP	2014-07-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2001-03-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2001-03-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2001-10-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2002-09-05	STANDARD
LABELING; Labeling	SUPPL	24	AP	2014-07-17	STANDARD
LABELING; Labeling	SUPPL	25	AP	2008-12-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	2011-02-01	STANDARD
LABELING; Labeling	SUPPL	28	AP	2014-07-17	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	14	Null	0
SUPPL	16	Null	7
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	24	Null	6
SUPPL	27	Null	0
SUPPL	28	Null	15

CDER Filings

MERCK SHARP DOHME

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19856
            [companyName] => MERCK SHARP DOHME
            [docInserts] => ["",""]
            [products] => [{"drugName":"SINEMET CR","activeIngredients":"CARBIDOPA; LEVODOPA","strength":"50MG;200MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"SINEMET CR","activeIngredients":"CARBIDOPA; LEVODOPA","strength":"25MG;100MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"07\/17\/2014","submission":"SUPPL-28","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/019856s016s024s028lbl.pdf\"}]","notes":""},{"actionDate":"07\/17\/2014","submission":"SUPPL-24","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/019856s016s024s028lbl.pdf\"}]","notes":""},{"actionDate":"07\/17\/2014","submission":"SUPPL-16","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/019856s016s024s028lbl.pdf\"}]","notes":""},{"actionDate":"02\/01\/2011","submission":"SUPPL-27","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/019856s027lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"12\/31\/2008","submission":"SUPPL-25","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/019856s025lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"SINEMET CR","submission":"CARBIDOPA; LEVODOPA","actionType":"50MG;200MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"SINEMET CR","submission":"CARBIDOPA; LEVODOPA","actionType":"25MG;100MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2014-07-17
        )

)