Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 077460

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ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE)
EQ 0.25MG BASE
Marketing Status: Discontinued

Active Ingredient: ROPINIROLE HYDROCHLORIDE
Proprietary Name: ROPINIROLE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 0.25MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A077460
Product Number: 001
Approval Date: May 5, 2008
Applicant Holder Full Name: COSETTE PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE)
EQ 0.5MG BASE
Marketing Status: Discontinued

Active Ingredient: ROPINIROLE HYDROCHLORIDE
Proprietary Name: ROPINIROLE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 0.5MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A077460
Product Number: 002
Approval Date: May 5, 2008
Applicant Holder Full Name: COSETTE PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE)
EQ 1MG BASE
Marketing Status: Discontinued

Active Ingredient: ROPINIROLE HYDROCHLORIDE
Proprietary Name: ROPINIROLE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 1MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A077460
Product Number: 003
Approval Date: May 5, 2008
Applicant Holder Full Name: COSETTE PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE)
EQ 2MG BASE
Marketing Status: Discontinued

Active Ingredient: ROPINIROLE HYDROCHLORIDE
Proprietary Name: ROPINIROLE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 2MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A077460
Product Number: 004
Approval Date: May 5, 2008
Applicant Holder Full Name: COSETTE PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE)
EQ 3MG BASE
Marketing Status: Discontinued

Active Ingredient: ROPINIROLE HYDROCHLORIDE
Proprietary Name: ROPINIROLE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 3MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A077460
Product Number: 005
Approval Date: May 5, 2008
Applicant Holder Full Name: COSETTE PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE)
EQ 4MG BASE
Marketing Status: Discontinued

Active Ingredient: ROPINIROLE HYDROCHLORIDE
Proprietary Name: ROPINIROLE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 4MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A077460
Product Number: 006
Approval Date: May 5, 2008
Applicant Holder Full Name: COSETTE PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE)
EQ 5MG BASE
Marketing Status: Discontinued

Active Ingredient: ROPINIROLE HYDROCHLORIDE
Proprietary Name: ROPINIROLE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 5MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A077460
Product Number: 007
Approval Date: May 19, 2008
Applicant Holder Full Name: COSETTE PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information