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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 203399

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NDA 203399 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 203399

Tradename:	METAXALONE
Applicant:	Amneal Pharms
Ingredient:	metaxalone
Patents:	0

Pharmacology for NDA: 203399

Physiological Effect	Centrally-mediated Muscle Relaxation

Suppliers and Packaging for NDA: 203399

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METAXALONE	metaxalone	TABLET;ORAL	203399	ANDA	AvKARE	42291-985	42291-985-50	500 TABLET in 1 BOTTLE (42291-985-50)
METAXALONE	metaxalone	TABLET;ORAL	203399	ANDA	AvKARE	42291-985	42291-985-01	100 TABLET in 1 BOTTLE (42291-985-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	800MG
Approval Date:	Jun 21, 2013	TE:	AB	RLD:	No

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