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Details for New Drug Application (NDA): 021627

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NDA 021627 describes NAMENDA, which is a drug marketed by Forest Labs Llc and is included in three NDAs. It is available from eight suppliers. There are eight 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. Thirty-five suppliers are listed for this compound. There are four tentative approvals for this compound. Additional details are available on the memantine hydrochloride profile page.

Summary for NDA: 021627

Forest Labs Llc
memantine hydrochloride
Therapeutic Class:Antidementia Agents

Pharmacology for NDA: 021627

Mechanism of ActionNMDA Receptor Antagonists

Suppliers and Packaging for NDA: 021627

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
memantine hydrochloride
SOLUTION;ORAL 021627 NDA Forest Laboratories, Inc. 0456-3202 0456-3202-12 360 mL in 1 BOTTLE (0456-3202-12)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength2MG/ML
Approval Date:Apr 18, 2005TE:AARLD:Yes
Patent:5,061,703*PEDPatent Expiration:Oct 11, 2015Product Flag?Substance Flag?Delist Request?

Expired Orange Book Patents for NDA: 021627

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Forest Labs Llc
memantine hydrochloride
SOLUTION;ORAL021627-001Apr 18, 20055,061,703*PED► subscribe
Forest Labs Llc
memantine hydrochloride
SOLUTION;ORAL021627-001Apr 18, 20055,614,560► subscribe
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