Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 078690

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

Active Ingredient: CARBIDOPA; LEVODOPA
Proprietary Name: CARBIDOPA AND LEVODOPA
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 10MG;100MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A078690
Product Number: 001
Approval Date: Jul 31, 2009
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

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

Active Ingredient: CARBIDOPA; LEVODOPA
Proprietary Name: CARBIDOPA AND LEVODOPA
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 25MG;100MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A078690
Product Number: 002
Approval Date: Jul 31, 2009
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

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

Active Ingredient: CARBIDOPA; LEVODOPA
Proprietary Name: CARBIDOPA AND LEVODOPA
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 25MG;250MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: 
Application Number: A078690
Product Number: 003
Approval Date: Jul 31, 2009
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information