Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 017555

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SINEMET (CARBIDOPA; LEVODOPA)
10MG;100MG
Marketing Status: Prescription

Active Ingredient: CARBIDOPA; LEVODOPA
Proprietary Name: SINEMET
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG;100MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N017555
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ORGANON LLC A SUB OF ORGANON AND CO
Marketing Status:  Prescription
Patent and Exclusivity Information

SINEMET (CARBIDOPA; LEVODOPA)
25MG;100MG
Marketing Status: Prescription

Active Ingredient: CARBIDOPA; LEVODOPA
Proprietary Name: SINEMET
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG;100MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N017555
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ORGANON LLC A SUB OF ORGANON AND CO
Marketing Status:  Prescription
Patent and Exclusivity Information

SINEMET (CARBIDOPA; LEVODOPA)
25MG;250MG
Marketing Status: Prescription

Active Ingredient: CARBIDOPA; LEVODOPA
Proprietary Name: SINEMET
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG;250MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N017555
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ORGANON LLC A SUB OF ORGANON AND CO
Marketing Status:  Prescription
Patent and Exclusivity Information