FDA.reportPublic FDA data

Application 017555

Type
NDA
Sponsor
MERCK SHARP DOHME

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SINEMETCARBIDOPA; LEVODOPATABLET;ORAL10MG;100MGYesNo
002SINEMETCARBIDOPA; LEVODOPATABLET;ORAL25MG;250MGYesYes
003SINEMETCARBIDOPA; LEVODOPATABLET;ORAL25MG;100MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0006-3915SINEMETcarbidopa and levodopaMerck Sharp & Dohme Corp.NDACurrent
0006-3915SINEMETcarbidopa and levodopaMerck Sharp & Dohme Corp.NDACurrent
0006-3915SINEMETcarbidopa and levodopaMerck Sharp & Dohme Corp.NDACurrent
0006-3915SINEMETcarbidopa and levodopaMerck Sharp & Dohme Corp.NDACurrent
0006-3916SINEMETcarbidopa and levodopaMerck Sharp & Dohme Corp.NDACurrent
0006-3916SINEMETcarbidopa and levodopaMerck Sharp & Dohme Corp.NDACurrent
0006-3916SINEMETcarbidopa and levodopaMerck Sharp & Dohme Corp.NDACurrent
0006-3916SINEMETcarbidopa and levodopaMerck Sharp & Dohme Corp.NDACurrent
0006-3917SINEMETcarbidopa and levodopaMerck Sharp & Dohme Corp.NDACurrent
0006-3917SINEMETcarbidopa and levodopaMerck Sharp & Dohme Corp.NDACurrent
0006-3917SINEMETcarbidopa and levodopaMerck Sharp & Dohme Corp.NDACurrent
0006-3917SINEMETcarbidopa and levodopaMerck Sharp & Dohme Corp.NDACurrent
0006-6722SINEMETcarbidopa and levodopaMerck Sharp & Dohme Corp.NDACurrent
0006-6722SINEMETcarbidopa and levodopaMerck Sharp & Dohme Corp.NDACurrent
0006-6723SINEMETcarbidopa and levodopaMerck Sharp & Dohme Corp.NDACurrent
0006-6723SINEMETcarbidopa and levodopaMerck Sharp & Dohme Corp.NDACurrent
0006-6724SINEMETcarbidopa and levodopaMerck Sharp & Dohme Corp.NDACurrent
0006-6724SINEMETcarbidopa and levodopaMerck Sharp & Dohme Corp.NDACurrent
78206-166SINEMETcarbidopa and levodopaOrganon LLCNDACurrent
78206-166SINEMETcarbidopa and levodopaOrganon LLCNDACurrent
78206-167SINEMETcarbidopa and levodopaOrganon LLCNDACurrent
78206-167SINEMETcarbidopa and levodopaOrganon LLCNDACurrent
78206-168SINEMETcarbidopa and levodopaOrganon LLCNDACurrent
78206-168SINEMETcarbidopa and levodopaOrganon LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85492SUPPL 2026-03-24
85439SUPPL 2026-03-23
62881SUPPL2020-05-11
13845SUPPL2014-07-23
13842SUPPL2014-07-23
635SUPPL2014-07-23
33299SUPPL2014-07-22
11024SUPPL2014-07-22
11022SUPPL2014-07-22
40750SUPPL2013-06-03
13844SUPPL2011-02-07
11023SUPPL2011-02-04
33300SUPPL2009-01-06
13843SUPPL2009-01-06
13841SUPPL2001-04-11
13840SUPPL2001-04-11
13839SUPPL2001-04-11
13838SUPPL2001-04-11
634SUPPL2001-04-11
633SUPPL2001-04-11
632SUPPL2001-04-11
631SUPPL2001-04-11
630SUPPL2001-04-11