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Serving 500+ biopharmaceutical companies globally:

Covington
QuintilesIMS
Johnson and Johnson
McKesson
Teva
Harvard Business School
Merck
Baxter
Cantor Fitzgerald
Chubb

Generated: August 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 017555

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NDA 017555 describes SINEMET, which is a drug marketed by 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. Thirty-one suppliers are listed for this compound. Additional details are available on the carbidopa; levodopa profile page.

Summary for NDA: 017555

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

Pharmacology for NDA: 017555

Ingredient-typeAmino Acids, Aromatic

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)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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

Expired Orange Book Patents for NDA: 017555

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme
SINEMET
carbidopa; levodopa
TABLET;ORAL017555-003Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Merck Sharp Dohme
SINEMET
carbidopa; levodopa
TABLET;ORAL017555-002Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Merck Sharp Dohme
SINEMET
carbidopa; levodopa
TABLET;ORAL017555-003Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Merck Sharp Dohme
SINEMET
carbidopa; levodopa
TABLET;ORAL017555-003Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Merck Sharp Dohme
SINEMET
carbidopa; levodopa
TABLET;ORAL017555-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Johnson and Johnson
US Department of Justice
AstraZeneca
Citi
Accenture
Deloitte
Moodys
Boehringer Ingelheim
Chubb
McKinsey

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