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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 suppliers are listed for this compound. Additional details are available on the carbidopa; levodopa profile page.

Summary for NDA: 019856

Tradename:
SINEMET CR
Applicant:
Merck Sharp Dohme
Ingredient:
carbidopa; levodopa
Patents:0
Therapeutic Class:Antiparkinson Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 019856

Mechanism of ActionDOPA Decarboxylase Inhibitors

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:No

Expired Orange Book Patents for NDA: 019856

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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, 19924,832,957► subscribe
Merck Sharp Dohme
SINEMET CR
carbidopa; levodopa
TABLET, EXTENDED RELEASE;ORAL019856-001May 30, 19914,900,755► subscribe
Merck Sharp Dohme
SINEMET CR
carbidopa; levodopa
TABLET, EXTENDED RELEASE;ORAL019856-001May 30, 19914,832,957► subscribe
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