Product Details for ANDA 076699
PARCOPA (CARBIDOPA; LEVODOPA)
10MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
25MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
25MG;250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
10MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: PARCOPA
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 10MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A076699
Product Number: 001
Approval Date: Aug 27, 2004
Applicant Holder Full Name: UCB INC
Marketing Status: Discontinued
Patent and Exclusivity Information
PARCOPA (CARBIDOPA; LEVODOPA)
Proprietary Name: PARCOPA
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 10MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A076699
Product Number: 001
Approval Date: Aug 27, 2004
Applicant Holder Full Name: UCB INC
Marketing Status: Discontinued
Patent and Exclusivity Information
25MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: PARCOPA
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 25MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A076699
Product Number: 002
Approval Date: Aug 27, 2004
Applicant Holder Full Name: UCB INC
Marketing Status: Discontinued
Patent and Exclusivity Information
PARCOPA (CARBIDOPA; LEVODOPA)
Proprietary Name: PARCOPA
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 25MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A076699
Product Number: 002
Approval Date: Aug 27, 2004
Applicant Holder Full Name: UCB INC
Marketing Status: Discontinued
Patent and Exclusivity Information
25MG;250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CARBIDOPA; LEVODOPA
Proprietary Name: PARCOPA
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 25MG;250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A076699
Product Number: 003
Approval Date: Aug 27, 2004
Applicant Holder Full Name: UCB INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: PARCOPA
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 25MG;250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A076699
Product Number: 003
Approval Date: Aug 27, 2004
Applicant Holder Full Name: UCB INC
Marketing Status: Discontinued
Patent and Exclusivity Information