Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 204403

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RIVASTIGMINE (RIVASTIGMINE)
4.6MG/24HR
Marketing Status: Prescription

Active Ingredient: RIVASTIGMINE
Proprietary Name: RIVASTIGMINE
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 4.6MG/24HR
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204403
Product Number: 001
Approval Date: Sep 3, 2015
Applicant Holder Full Name: ALVOGEN INC
Marketing Status:  Prescription
Patent and Exclusivity Information

RIVASTIGMINE (RIVASTIGMINE)
9.5MG/24HR
Marketing Status: Prescription

Active Ingredient: RIVASTIGMINE
Proprietary Name: RIVASTIGMINE
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 9.5MG/24HR
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204403
Product Number: 002
Approval Date: Sep 3, 2015
Applicant Holder Full Name: ALVOGEN INC
Marketing Status:  Prescription
Patent and Exclusivity Information

RIVASTIGMINE (RIVASTIGMINE)
13.3MG/24HR
Marketing Status: Prescription

Active Ingredient: RIVASTIGMINE
Proprietary Name: RIVASTIGMINE
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 13.3MG/24HR
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204403
Product Number: 003
Approval Date: Aug 31, 2015
Applicant Holder Full Name: ALVOGEN INC
Marketing Status:  Prescription
Patent and Exclusivity Information