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Serving leading biopharmaceutical companies globally:

UBS
Chubb
Novartis
Covington
US Department of Justice
Moodys
Merck
McKinsey
Baxter
Daiichi Sankyo

Generated: October 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 019856

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NDA 019856 describes SINEMET CR, which is a drug marketed by Merck Sharp Dohme and is included in one NDA. It is available from one supplier. 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-two suppliers are listed for this compound. Additional details are available on the carbidopa; levodopa profile page.

Summary for NDA: 019856

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antiparkinson Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 019856

Ingredient-typeAmino Acids, Aromatic

Suppliers and Packaging for NDA: 019856

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SINEMET CR
carbidopa; levodopa
TABLET, EXTENDED RELEASE;ORAL 019856 NDA Merck Sharp & Dohme Corp. 0006-3918 0006-3918-68 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0006-3918-68)
SINEMET CR
carbidopa; levodopa
TABLET, EXTENDED RELEASE;ORAL 019856 NDA Merck Sharp & Dohme Corp. 0006-3919 0006-3919-68 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0006-3919-68)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength50MG;200MG
Approval Date:May 30, 1991TE:ABRLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength25MG;100MG
Approval Date:Dec 24, 1992TE:ABRLD:Yes

Expired Orange Book Patents for NDA: 019856

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme
SINEMET CR
carbidopa; levodopa
TABLET, EXTENDED RELEASE;ORAL019856-002Dec 24, 1992► Subscribe► Subscribe
Merck Sharp Dohme
SINEMET CR
carbidopa; levodopa
TABLET, EXTENDED RELEASE;ORAL019856-001May 30, 1991► Subscribe► Subscribe
Merck Sharp Dohme
SINEMET CR
carbidopa; levodopa
TABLET, EXTENDED RELEASE;ORAL019856-001May 30, 1991► Subscribe► Subscribe
Merck Sharp Dohme
SINEMET CR
carbidopa; levodopa
TABLET, EXTENDED RELEASE;ORAL019856-001May 30, 1991► Subscribe► Subscribe
Merck Sharp Dohme
SINEMET CR
carbidopa; levodopa
TABLET, EXTENDED RELEASE;ORAL019856-002Dec 24, 1992► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Baxter
Covington
Daiichi Sankyo
Accenture
McKesson
Cerilliant
Teva
Novartis
Citi
Moodys

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