Details for New Drug Application (NDA): 019856

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NDA 019856 describes SINEMET CR, which is a drug marketed by Organon Llc and is included in one NDA. Additional details are available on the SINEMET CR profile page.

The generic ingredient in SINEMET CR 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 019856

Tradename:	SINEMET CR
Applicant:	Organon Llc
Ingredient:	carbidopa; levodopa
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	50MG;200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	May 30, 1991	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	25MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 24, 1992	TE:		RLD:	Yes

Expired US Patents for NDA 019856

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon Llc	SINEMET CR	carbidopa; levodopa	TABLET, EXTENDED RELEASE;ORAL	019856-001	May 30, 1991	⤷ Sign Up	⤷ Sign Up
Organon Llc	SINEMET CR	carbidopa; levodopa	TABLET, EXTENDED RELEASE;ORAL	019856-002	Dec 24, 1992	⤷ Sign Up	⤷ Sign Up
Organon Llc	SINEMET CR	carbidopa; levodopa	TABLET, EXTENDED RELEASE;ORAL	019856-001	May 30, 1991	⤷ Sign Up	⤷ Sign Up
Organon Llc	SINEMET CR	carbidopa; levodopa	TABLET, EXTENDED RELEASE;ORAL	019856-002	Dec 24, 1992	⤷ Sign Up	⤷ Sign Up
Organon Llc	SINEMET CR	carbidopa; levodopa	TABLET, EXTENDED RELEASE;ORAL	019856-001	May 30, 1991	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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