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Last Updated: December 7, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021487

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NDA 021487 describes NAMENDA, which is a drug marketed by Allergan Sales Llc and Forest Labs Llc and is included in three NDAs. It is available from six suppliers. There are seven patents protecting this drug and five Paragraph IV challenges. Additional details are available on the NAMENDA profile page.

The generic ingredient in NAMENDA is memantine hydrochloride. There are twenty-eight drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the memantine hydrochloride profile page.
Summary for 021487
Tradename:NAMENDA
Applicant:Allergan Sales Llc
Ingredient:memantine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 021487
Mechanism of ActionNMDA Receptor Antagonists
Medical Subject Heading (MeSH) Categories for 021487
Suppliers and Packaging for NDA: 021487
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NAMENDA memantine hydrochloride TABLET;ORAL 021487 NDA Allergan, Inc. 0456-3200 0456-3200-14 1 KIT in 1 BLISTER PACK (0456-3200-14)
NAMENDA memantine hydrochloride TABLET;ORAL 021487 NDA Allergan, Inc. 0456-3205 0456-3205-60 60 TABLET in 1 BOTTLE (0456-3205-60)
Paragraph IV (Patent) Challenges for 021487
Tradename Dosage Ingredient NDA Submissiondate
NAMENDA TABLET;ORAL memantine hydrochloride 021487 2007-10-16

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Oct 16, 2003TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Oct 16, 2003TE:ABRLD:Yes

Expired US Patents for NDA 021487

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan Sales Llc NAMENDA memantine hydrochloride TABLET;ORAL 021487-001 Oct 16, 2003   Start Trial   Start Trial
Allergan Sales Llc NAMENDA memantine hydrochloride TABLET;ORAL 021487-002 Oct 16, 2003   Start Trial   Start Trial
Allergan Sales Llc NAMENDA memantine hydrochloride TABLET;ORAL 021487-002 Oct 16, 2003   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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