Last Updated: September 25, 2026

Details for New Drug Application (NDA): 204770

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NDA 204770 describes METAXALONE, which is a drug marketed by Actavis Labs Fl Inc, Amneal Pharms, Ingenus Pharms Llc, Lannett Co Inc, Mountain, Primus Pharms, Rising, Sandoz, and Sciegen Pharms, and is included in nine NDAs. It is available from thirty-five suppliers. There are two patents protecting this drug. Additional details are available on the METAXALONE profile page.

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

Summary for 204770

Tradename:	METAXALONE
Applicant:	Lannett Co Inc
Ingredient:	metaxalone
Patents:	0

Pharmacology for NDA: 204770

Physiological Effect	Centrally-mediated Muscle Relaxation

Suppliers and Packaging for NDA: 204770

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METAXALONE	metaxalone	TABLET;ORAL	204770	ANDA	Lannett Company, Inc.	0527-1435	0527-1435-01	100 TABLET in 1 BOTTLE (0527-1435-01)
METAXALONE	metaxalone	TABLET;ORAL	204770	ANDA	Lannett Company, Inc.	0527-1435	0527-1435-05	500 TABLET in 1 BOTTLE (0527-1435-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	800MG
Approval Date:	Nov 22, 2016	TE:	AB	RLD:	No

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