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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 206439

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NAMZARIC (DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE)
10MG;7MG
Marketing Status: Prescription
Active Ingredient: DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
Proprietary Name: NAMZARIC
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 10MG;7MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N206439
Product Number: 003
Approval Date: Jul 18, 2016
Applicant Holder Full Name: ABBVIE INC
Marketing Status:  Prescription
Patent and Exclusivity Information
NAMZARIC (DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE)
10MG;14MG
Marketing Status: Prescription
Active Ingredient: DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
Proprietary Name: NAMZARIC
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 10MG;14MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N206439
Product Number: 001
Approval Date: Dec 23, 2014
Applicant Holder Full Name: ABBVIE INC
Marketing Status:  Prescription
Patent and Exclusivity Information
NAMZARIC (DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE)
10MG;21MG
Marketing Status: Prescription
Active Ingredient: DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
Proprietary Name: NAMZARIC
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 10MG;21MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N206439
Product Number: 004
Approval Date: Jul 18, 2016
Applicant Holder Full Name: ABBVIE INC
Marketing Status:  Prescription
Patent and Exclusivity Information
NAMZARIC (DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE)
10MG;28MG
Marketing Status: Prescription
Active Ingredient: DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
Proprietary Name: NAMZARIC
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 10MG;28MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N206439
Product Number: 002
Approval Date: Dec 23, 2014
Applicant Holder Full Name: ABBVIE INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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