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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022525

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NAMENDA XR (MEMANTINE HYDROCHLORIDE)
14MG
Marketing Status: Prescription
Active Ingredient: MEMANTINE HYDROCHLORIDE
Proprietary Name: NAMENDA XR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 14MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022525
Product Number: 002
Approval Date: Jun 21, 2010
Applicant Holder Full Name: ABBVIE INC
Marketing Status:  Prescription
Patent and Exclusivity Information
NAMENDA XR (MEMANTINE HYDROCHLORIDE)
21MG
Marketing Status: Prescription
Active Ingredient: MEMANTINE HYDROCHLORIDE
Proprietary Name: NAMENDA XR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 21MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022525
Product Number: 003
Approval Date: Jun 21, 2010
Applicant Holder Full Name: ABBVIE INC
Marketing Status:  Prescription
Patent and Exclusivity Information
NAMENDA XR (MEMANTINE HYDROCHLORIDE)
28MG
Marketing Status: Prescription
Active Ingredient: MEMANTINE HYDROCHLORIDE
Proprietary Name: NAMENDA XR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 28MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N022525
Product Number: 004
Approval Date: Jun 21, 2010
Applicant Holder Full Name: ABBVIE INC
Marketing Status:  Prescription
Patent and Exclusivity Information
NAMENDA XR (MEMANTINE HYDROCHLORIDE)
7MG
Marketing Status: Discontinued
Active Ingredient: MEMANTINE HYDROCHLORIDE
Proprietary Name: NAMENDA XR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 7MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022525
Product Number: 001
Approval Date: Jun 21, 2010
Applicant Holder Full Name: ABBVIE INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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