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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 090833

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CARBIDOPA, LEVODOPA AND ENTACAPONE (CARBIDOPA; ENTACAPONE; LEVODOPA)
18.75MG;200MG;75MG
Marketing Status: Discontinued
Active Ingredient: CARBIDOPA; ENTACAPONE; LEVODOPA
Proprietary Name: CARBIDOPA, LEVODOPA AND ENTACAPONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 18.75MG;200MG;75MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A090833
Product Number: 001
Approval Date: Nov 20, 2012
Applicant Holder Full Name: WOCKHARDT LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
CARBIDOPA, LEVODOPA AND ENTACAPONE (CARBIDOPA; ENTACAPONE; LEVODOPA)
25MG;200MG;100MG
Marketing Status: Discontinued
Active Ingredient: CARBIDOPA; ENTACAPONE; LEVODOPA
Proprietary Name: CARBIDOPA, LEVODOPA AND ENTACAPONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG;200MG;100MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A090833
Product Number: 002
Approval Date: Nov 20, 2012
Applicant Holder Full Name: WOCKHARDT LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
CARBIDOPA, LEVODOPA AND ENTACAPONE (CARBIDOPA; ENTACAPONE; LEVODOPA)
31.25MG;200MG;125MG
Marketing Status: Discontinued
Active Ingredient: CARBIDOPA; ENTACAPONE; LEVODOPA
Proprietary Name: CARBIDOPA, LEVODOPA AND ENTACAPONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 31.25MG;200MG;125MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A090833
Product Number: 003
Approval Date: Nov 20, 2012
Applicant Holder Full Name: WOCKHARDT LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
CARBIDOPA, LEVODOPA AND ENTACAPONE (CARBIDOPA; ENTACAPONE; LEVODOPA)
37.5MG;200MG;150MG
Marketing Status: Discontinued
Active Ingredient: CARBIDOPA; ENTACAPONE; LEVODOPA
Proprietary Name: CARBIDOPA, LEVODOPA AND ENTACAPONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 37.5MG;200MG;150MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A090833
Product Number: 004
Approval Date: Nov 20, 2012
Applicant Holder Full Name: WOCKHARDT LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
CARBIDOPA, LEVODOPA AND ENTACAPONE (CARBIDOPA; ENTACAPONE; LEVODOPA)
50MG;200MG;200MG
Marketing Status: Discontinued
Active Ingredient: CARBIDOPA; ENTACAPONE; LEVODOPA
Proprietary Name: CARBIDOPA, LEVODOPA AND ENTACAPONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG;200MG;200MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A090833
Product Number: 005
Approval Date: Nov 20, 2012
Applicant Holder Full Name: WOCKHARDT LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
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