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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 022525


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NDA 022525 describes NAMENDA XR, which is a drug marketed by Abbvie and is included in one NDA. It is available from one supplier. There is one patent protecting this drug and four Paragraph IV challenges. Additional details are available on the NAMENDA XR profile page.

The generic ingredient in NAMENDA XR is memantine hydrochloride. There are twenty-eight drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the memantine hydrochloride profile page.
Summary for 022525
Tradename:NAMENDA XR
Applicant:Abbvie
Ingredient:memantine hydrochloride
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 022525
Mechanism of ActionNMDA Receptor Antagonists
Medical Subject Heading (MeSH) Categories for 022525
Suppliers and Packaging for NDA: 022525
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NAMENDA XR memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022525 NDA Allergan, Inc. 0456-3414 0456-3414-33 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0456-3414-33)
NAMENDA XR memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022525 NDA Allergan, Inc. 0456-3421 0456-3421-33 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0456-3421-33)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, EXTENDED RELEASE;ORALStrength7MG
Approval Date:Jun 21, 2010TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Sep 24, 2029Product Flag?Substance Flag?Delist Request?Y

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength14MG
Approval Date:Jun 21, 2010TE:ABRLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Sep 24, 2029Product Flag?Substance Flag?Delist Request?Y

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength21MG
Approval Date:Jun 21, 2010TE:ABRLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Sep 24, 2029Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 022525

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie NAMENDA XR memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022525-001 Jun 21, 2010 ⤷  Try a Trial ⤷  Try a Trial
Abbvie NAMENDA XR memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022525-004 Jun 21, 2010 ⤷  Try a Trial ⤷  Try a Trial
Abbvie NAMENDA XR memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022525-002 Jun 21, 2010 ⤷  Try a Trial ⤷  Try a Trial
Abbvie NAMENDA XR memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022525-003 Jun 21, 2010 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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