Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021829

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NEUPRO (ROTIGOTINE)
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)
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)
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)
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)
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)
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

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