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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 040486

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NDA 040486 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 040486

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

Pharmacology for NDA: 040486

Physiological Effect	Centrally-mediated Muscle Relaxation

Suppliers and Packaging for NDA: 040486

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METAXALONE	metaxalone	TABLET;ORAL	040486	ANDA	Amneal Pharmaceuticals of New York LLC	0115-1745	0115-1745-01	100 TABLET in 1 BOTTLE (0115-1745-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	400MG
Approval Date:	Feb 27, 2015	TE:	AB	RLD:	No

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