Product Details for NDA 021485
STALEVO 100 (CARBIDOPA; ENTACAPONE; LEVODOPA)
25MG;200MG;100MG
Marketing Status: Prescription
31.25MG;200MG;125MG
Marketing Status: Prescription
37.5MG;200MG;150MG
Marketing Status: Prescription
50MG;200MG;200MG
Marketing Status: Prescription
12.5MG;200MG;50MG
Marketing Status: Prescription
18.75MG;200MG;75MG
Marketing Status: Prescription
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)
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
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)
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
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)
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
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)
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
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)
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
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
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