Product Details for NDA 021829
NEUPRO (ROTIGOTINE)
1MG/24HR
Marketing Status: Prescription
2MG/24HR
Marketing Status: Prescription
3MG/24HR
Marketing Status: Prescription
4MG/24HR
Marketing Status: Prescription
6MG/24HR
Marketing Status: Prescription
8MG/24HR
Marketing Status: Prescription
1MG/24HR
Marketing Status: Prescription
Active Ingredient: ROTIGOTINE
Proprietary Name: NEUPRO
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 1MG/24HR
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021829
Product Number: 004
Approval Date: Apr 2, 2012
Applicant Holder Full Name: UCB INC
Marketing Status: Prescription
Patent and Exclusivity Information
NEUPRO (ROTIGOTINE)
Proprietary Name: NEUPRO
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 1MG/24HR
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021829
Product Number: 004
Approval Date: Apr 2, 2012
Applicant Holder Full Name: UCB INC
Marketing Status: Prescription
Patent and Exclusivity Information
2MG/24HR
Marketing Status: Prescription
Active Ingredient: ROTIGOTINE
Proprietary Name: NEUPRO
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 2MG/24HR
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N021829
Product Number: 001
Approval Date: May 9, 2007
Applicant Holder Full Name: UCB INC
Marketing Status: Prescription
Patent and Exclusivity Information
NEUPRO (ROTIGOTINE)
Proprietary Name: NEUPRO
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 2MG/24HR
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N021829
Product Number: 001
Approval Date: May 9, 2007
Applicant Holder Full Name: UCB INC
Marketing Status: Prescription
Patent and Exclusivity Information
3MG/24HR
Marketing Status: Prescription
Active Ingredient: ROTIGOTINE
Proprietary Name: NEUPRO
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 3MG/24HR
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021829
Product Number: 005
Approval Date: Apr 2, 2012
Applicant Holder Full Name: UCB INC
Marketing Status: Prescription
Patent and Exclusivity Information
NEUPRO (ROTIGOTINE)
Proprietary Name: NEUPRO
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 3MG/24HR
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021829
Product Number: 005
Approval Date: Apr 2, 2012
Applicant Holder Full Name: UCB INC
Marketing Status: Prescription
Patent and Exclusivity Information
4MG/24HR
Marketing Status: Prescription
Active Ingredient: ROTIGOTINE
Proprietary Name: NEUPRO
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 4MG/24HR
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021829
Product Number: 002
Approval Date: May 9, 2007
Applicant Holder Full Name: UCB INC
Marketing Status: Prescription
Patent and Exclusivity Information
NEUPRO (ROTIGOTINE)
Proprietary Name: NEUPRO
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 4MG/24HR
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021829
Product Number: 002
Approval Date: May 9, 2007
Applicant Holder Full Name: UCB INC
Marketing Status: Prescription
Patent and Exclusivity Information
6MG/24HR
Marketing Status: Prescription
Active Ingredient: ROTIGOTINE
Proprietary Name: NEUPRO
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 6MG/24HR
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021829
Product Number: 003
Approval Date: May 9, 2007
Applicant Holder Full Name: UCB INC
Marketing Status: Prescription
Patent and Exclusivity Information
NEUPRO (ROTIGOTINE)
Proprietary Name: NEUPRO
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 6MG/24HR
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021829
Product Number: 003
Approval Date: May 9, 2007
Applicant Holder Full Name: UCB INC
Marketing Status: Prescription
Patent and Exclusivity Information
8MG/24HR
Marketing Status: Prescription
Active Ingredient: ROTIGOTINE
Proprietary Name: NEUPRO
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 8MG/24HR
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021829
Product Number: 006
Approval Date: Apr 2, 2012
Applicant Holder Full Name: UCB INC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: NEUPRO
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 8MG/24HR
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021829
Product Number: 006
Approval Date: Apr 2, 2012
Applicant Holder Full Name: UCB INC
Marketing Status: Prescription
Patent and Exclusivity Information