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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 040445

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NDA 040445 describes METAXALONE, which is a drug marketed by Actavis Labs Fl Inc, Amneal Pharms, Lannett Co Inc, Mountain, Novast Labs, Primus Pharms, Rising, Sandoz, and Sciegen Pharms, and is included in nine NDAs. It is available from thirty-two suppliers. There is one patent protecting this drug. Additional details are available on the METAXALONE profile page.

The generic ingredient in METAXALONE is metaxalone. There are twenty drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the metaxalone profile page.

Summary for 040445

Tradename:	METAXALONE
Applicant:	Sandoz
Ingredient:	metaxalone
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	800MG
Approval Date:	Mar 31, 2010	TE:	AB	RLD:	No

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