Details for New Drug Application (NDA): 207466

NDA 207466 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 Inc, and is included in nine NDAs. It is available from thirty-four 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-four suppliers are listed for this compound. Additional details are available on the metaxalone profile page.

Summary for 207466

Tradename:	METAXALONE
Applicant:	Sciegen Pharms Inc
Ingredient:	metaxalone
Patents:	0

Pharmacology for NDA: 207466

Physiological Effect

Centrally-mediated Muscle Relaxation

Suppliers and Packaging for NDA: 207466

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METAXALONE	metaxalone	TABLET;ORAL	207466	ANDA	Misemer Pharmaceuticals, Inc.	0276-0508	0276-0508-10	100 TABLET in 1 BOTTLE (0276-0508-10)
METAXALONE	metaxalone	TABLET;ORAL	207466	ANDA	Major Pharmaceuticals	0904-6831	0904-6831-04	30 BLISTER PACK in 1 CARTON (0904-6831-04) / 1 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	800MG
Approval Date:	Aug 31, 2017	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	400MG
Approval Date:	Mar 13, 2020	TE:	AB	RLD:	No

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