Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021485

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STALEVO 100 (CARBIDOPA; ENTACAPONE; LEVODOPA)
25MG;200MG;100MG
Marketing Status: Prescription

Active Ingredient: CARBIDOPA; ENTACAPONE; LEVODOPA
Proprietary Name: STALEVO 100
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG;200MG;100MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021485
Product Number: 002
Approval Date: Jun 11, 2003
Applicant Holder Full Name: ORION PHARMA
Marketing Status:  Prescription
Patent and Exclusivity Information

STALEVO 125 (CARBIDOPA; ENTACAPONE; LEVODOPA)
31.25MG;200MG;125MG
Marketing Status: Prescription

Active Ingredient: CARBIDOPA; ENTACAPONE; LEVODOPA
Proprietary Name: STALEVO 125
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 31.25MG;200MG;125MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021485
Product Number: 006
Approval Date: Aug 29, 2008
Applicant Holder Full Name: ORION PHARMA
Marketing Status:  Prescription
Patent and Exclusivity Information

STALEVO 150 (CARBIDOPA; ENTACAPONE; LEVODOPA)
37.5MG;200MG;150MG
Marketing Status: Prescription

Active Ingredient: CARBIDOPA; ENTACAPONE; LEVODOPA
Proprietary Name: STALEVO 150
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 37.5MG;200MG;150MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021485
Product Number: 003
Approval Date: Jun 11, 2003
Applicant Holder Full Name: ORION PHARMA
Marketing Status:  Prescription
Patent and Exclusivity Information

STALEVO 200 (CARBIDOPA; ENTACAPONE; LEVODOPA)
50MG;200MG;200MG
Marketing Status: Prescription

Active Ingredient: CARBIDOPA; ENTACAPONE; LEVODOPA
Proprietary Name: STALEVO 200
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG;200MG;200MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021485
Product Number: 004
Approval Date: Aug 2, 2007
Applicant Holder Full Name: ORION PHARMA
Marketing Status:  Prescription
Patent and Exclusivity Information

STALEVO 50 (CARBIDOPA; ENTACAPONE; LEVODOPA)
12.5MG;200MG;50MG
Marketing Status: Prescription

Active Ingredient: CARBIDOPA; ENTACAPONE; LEVODOPA
Proprietary Name: STALEVO 50
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 12.5MG;200MG;50MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021485
Product Number: 001
Approval Date: Jun 11, 2003
Applicant Holder Full Name: ORION PHARMA
Marketing Status:  Prescription
Patent and Exclusivity Information

STALEVO 75 (CARBIDOPA; ENTACAPONE; LEVODOPA)
18.75MG;200MG;75MG
Marketing Status: Prescription

Active Ingredient: CARBIDOPA; ENTACAPONE; LEVODOPA
Proprietary Name: STALEVO 75
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 18.75MG;200MG;75MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021485
Product Number: 005
Approval Date: Aug 29, 2008
Applicant Holder Full Name: ORION PHARMA
Marketing Status:  Prescription
Patent and Exclusivity Information