Product Details for ANDA 078110
ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE)
EQ 0.25MG BASE
Marketing Status: Prescription
EQ 0.5MG BASE
Marketing Status: Prescription
EQ 1MG BASE
Marketing Status: Prescription
EQ 2MG BASE
Marketing Status: Prescription
EQ 3MG BASE
Marketing Status: Prescription
EQ 4MG BASE
Marketing Status: Prescription
EQ 5MG BASE
Marketing Status: Prescription
EQ 0.25MG BASE
Marketing Status: Prescription
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: Yes
TE Code: AB
Application Number: A078110
Product Number: 001
Approval Date: May 5, 2008
Applicant Holder Full Name: PRINSTON PHARMACEUTICAL INC
Marketing Status: Prescription
Patent and Exclusivity Information
ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE)
Proprietary Name: ROPINIROLE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 0.25MG BASE
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AB
Application Number: A078110
Product Number: 001
Approval Date: May 5, 2008
Applicant Holder Full Name: PRINSTON PHARMACEUTICAL INC
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 0.5MG BASE
Marketing Status: Prescription
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: AB
Application Number: A078110
Product Number: 002
Approval Date: May 5, 2008
Applicant Holder Full Name: PRINSTON PHARMACEUTICAL INC
Marketing Status: Prescription
Patent and Exclusivity Information
ROPINIROLE HYDROCHLORIDE (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: AB
Application Number: A078110
Product Number: 002
Approval Date: May 5, 2008
Applicant Holder Full Name: PRINSTON PHARMACEUTICAL INC
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 1MG BASE
Marketing Status: Prescription
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: AB
Application Number: A078110
Product Number: 003
Approval Date: May 5, 2008
Applicant Holder Full Name: PRINSTON PHARMACEUTICAL INC
Marketing Status: Prescription
Patent and Exclusivity Information
ROPINIROLE HYDROCHLORIDE (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: AB
Application Number: A078110
Product Number: 003
Approval Date: May 5, 2008
Applicant Holder Full Name: PRINSTON PHARMACEUTICAL INC
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 2MG BASE
Marketing Status: Prescription
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: AB
Application Number: A078110
Product Number: 004
Approval Date: May 5, 2008
Applicant Holder Full Name: PRINSTON PHARMACEUTICAL INC
Marketing Status: Prescription
Patent and Exclusivity Information
ROPINIROLE HYDROCHLORIDE (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: AB
Application Number: A078110
Product Number: 004
Approval Date: May 5, 2008
Applicant Holder Full Name: PRINSTON PHARMACEUTICAL INC
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 3MG BASE
Marketing Status: Prescription
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: AB
Application Number: A078110
Product Number: 005
Approval Date: May 5, 2008
Applicant Holder Full Name: PRINSTON PHARMACEUTICAL INC
Marketing Status: Prescription
Patent and Exclusivity Information
ROPINIROLE HYDROCHLORIDE (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: AB
Application Number: A078110
Product Number: 005
Approval Date: May 5, 2008
Applicant Holder Full Name: PRINSTON PHARMACEUTICAL INC
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 4MG BASE
Marketing Status: Prescription
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: AB
Application Number: A078110
Product Number: 006
Approval Date: May 5, 2008
Applicant Holder Full Name: PRINSTON PHARMACEUTICAL INC
Marketing Status: Prescription
Patent and Exclusivity Information
ROPINIROLE HYDROCHLORIDE (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: AB
Application Number: A078110
Product Number: 006
Approval Date: May 5, 2008
Applicant Holder Full Name: PRINSTON PHARMACEUTICAL INC
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 5MG BASE
Marketing Status: Prescription
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: AB
Application Number: A078110
Product Number: 007
Approval Date: Jul 11, 2008
Applicant Holder Full Name: PRINSTON PHARMACEUTICAL INC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: ROPINIROLE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 5MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078110
Product Number: 007
Approval Date: Jul 11, 2008
Applicant Holder Full Name: PRINSTON PHARMACEUTICAL INC
Marketing Status: Prescription
Patent and Exclusivity Information