Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 019856

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SINEMET CR (CARBIDOPA; LEVODOPA)
25MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: CARBIDOPA; LEVODOPA
Proprietary Name: SINEMET CR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 25MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N019856
Product Number: 002
Approval Date: Dec 24, 1992
Applicant Holder Full Name: ORGANON LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information

SINEMET CR (CARBIDOPA; LEVODOPA)
50MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: CARBIDOPA; LEVODOPA
Proprietary Name: SINEMET CR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 50MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N019856
Product Number: 001
Approval Date: May 30, 1991
Applicant Holder Full Name: ORGANON LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information