Details for New Drug Application (NDA): 017555

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NDA 017555 describes SINEMET, which is a drug marketed by Organon and Organon Llc 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. Thirty-five 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	Organon LLC	78206-166	78206-166-01	100 TABLET in 1 BOTTLE (78206-166-01)
SINEMET	carbidopa; levodopa	TABLET;ORAL	017555	NDA	Organon LLC	78206-167	78206-167-01	100 TABLET in 1 BOTTLE (78206-167-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG;100MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG;250MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG;100MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Expired US Patents for NDA 017555

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	SINEMET	carbidopa; levodopa	TABLET;ORAL	017555-003	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Organon	SINEMET	carbidopa; levodopa	TABLET;ORAL	017555-003	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Organon	SINEMET	carbidopa; levodopa	TABLET;ORAL	017555-003	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Organon	SINEMET	carbidopa; levodopa	TABLET;ORAL	017555-002	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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