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Last Updated: October 24, 2021

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Details for New Drug Application (NDA): 017555


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NDA 017555 describes SINEMET, which is a drug marketed by Organon and Merck Sharp Dohme and is included in two NDAs. It is available from one supplier. Additional details are available on the SINEMET profile page.

The generic ingredient in SINEMET is carbidopa; levodopa. There are eighteen drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the carbidopa; levodopa profile page.
Summary for 017555
Tradename:SINEMET
Applicant:Organon
Ingredient:carbidopa; levodopa
Patents:0
Pharmacology for NDA: 017555
Suppliers and Packaging for NDA: 017555
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SINEMET carbidopa; levodopa TABLET;ORAL 017555 NDA Merck Sharp & Dohme Corp. 0006-3915 0006-3915-68 100 TABLET in 1 BOTTLE (0006-3915-68)
SINEMET carbidopa; levodopa TABLET;ORAL 017555 NDA Merck Sharp & Dohme Corp. 0006-3916 0006-3916-68 100 TABLET in 1 BOTTLE (0006-3916-68)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG;100MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG;250MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG;100MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Expired US Patents for NDA 017555

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon SINEMET carbidopa; levodopa TABLET;ORAL 017555-001 Approved Prior to Jan 1, 1982 ⤷  Free Forever Trial ⤷  Free Forever Trial
Organon SINEMET carbidopa; levodopa TABLET;ORAL 017555-002 Approved Prior to Jan 1, 1982 ⤷  Free Forever Trial ⤷  Free Forever Trial
Organon SINEMET carbidopa; levodopa TABLET;ORAL 017555-002 Approved Prior to Jan 1, 1982 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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