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U.S. Department of Health and Human Services

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Search results from the "OB_Rx" table for query on "021485."



Active Ingredient: CARBIDOPA; ENTACAPONE; LEVODOPA
Dosage Form;Route: TABLET;ORAL
Proprietary Name: STALEVO 50
Applicant: ORION PHARMA
Strength: 12.5MG;200MG;50MG
Application Number: N021485
Product Number: 001
Approval Date: Jun 11, 2003
Reference Listed Drug Yes
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View

Active Ingredient: CARBIDOPA; ENTACAPONE; LEVODOPA
Dosage Form;Route: TABLET;ORAL
Proprietary Name: STALEVO 100
Applicant: ORION PHARMA
Strength: 25MG;200MG;100MG
Application Number: N021485
Product Number: 002
Approval Date: Jun 11, 2003
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View

Active Ingredient: CARBIDOPA; ENTACAPONE; LEVODOPA
Dosage Form;Route: TABLET;ORAL
Proprietary Name: STALEVO 150
Applicant: ORION PHARMA
Strength: 37.5MG;200MG;150MG
Application Number: N021485
Product Number: 003
Approval Date: Jun 11, 2003
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View

Active Ingredient: CARBIDOPA; ENTACAPONE; LEVODOPA
Dosage Form;Route: TABLET;ORAL
Proprietary Name: STALEVO 200
Applicant: ORION PHARMA
Strength: 50MG;200MG;200MG
Application Number: N021485
Product Number: 004
Approval Date: Aug 2, 2007
Reference Listed Drug Yes
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View

Active Ingredient: CARBIDOPA; ENTACAPONE; LEVODOPA
Dosage Form;Route: TABLET;ORAL
Proprietary Name: STALEVO 75
Applicant: ORION PHARMA
Strength: 18.75MG;200MG;75MG
Application Number: N021485
Product Number: 005
Approval Date: Aug 29, 2008
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View

Active Ingredient: CARBIDOPA; ENTACAPONE; LEVODOPA
Dosage Form;Route: TABLET;ORAL
Proprietary Name: STALEVO 125
Applicant: ORION PHARMA
Strength: 31.25MG;200MG;125MG
Application Number: N021485
Product Number: 006
Approval Date: Aug 29, 2008
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View

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FDA/Center for Drug Evaluation and Research
Office of Generic Drugs
Division of Labeling and Program Support
Update Frequency:

Orange Book Data - Monthly
Generic Drug Product Information & Patent Information - Daily
Orange Book Data Updated Through August 2014
Patent and Generic Drug Product Data Last Updated October 01, 2014

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