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Details for New Drug Application (NDA): 021487

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NDA 021487 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: 021487

Tradename:
NAMENDA
Applicant:
Forest Labs Llc
Ingredient:
memantine hydrochloride
Patents:1
Therapeutic Class:Antidementia Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 021487

Mechanism of ActionNMDA Receptor Antagonists

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 Forest Laboratories, Inc. 0456-3200 0456-3200-14 1 KIT in 1 BLISTER PACK (0456-3200-14)
NAMENDA
memantine hydrochloride
TABLET;ORAL 021487 NDA Forest Laboratories, Inc. 0456-3205 0456-3205-60 60 TABLET in 1 BOTTLE (0456-3205-60)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Oct 16, 2003TE:ABRLD:No
Patent:5,061,703*PEDPatent Expiration:Oct 11, 2015Product Flag?Substance Flag?Delist Request?

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Oct 16, 2003TE:ABRLD:Yes
Patent:5,061,703*PEDPatent Expiration:Oct 11, 2015Product Flag?Substance Flag?Delist Request?

Expired Orange Book Patents for NDA: 021487

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Forest Labs Llc
NAMENDA
memantine hydrochloride
TABLET;ORAL021487-001Oct 16, 20035,061,703*PED► subscribe
Forest Labs Llc
NAMENDA
memantine hydrochloride
TABLET;ORAL021487-002Oct 16, 20035,614,560► subscribe
Forest Labs Llc
NAMENDA
memantine hydrochloride
TABLET;ORAL021487-002Oct 16, 20035,061,703*PED► subscribe
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