Details for New Drug Application (NDA): 013217

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NDA 013217 describes SKELAXIN, which is a drug marketed by King Pharms and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the SKELAXIN profile page.

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

Summary for 013217

Tradename:	SKELAXIN
Applicant:	King Pharms
Ingredient:	metaxalone
Patents:	1

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Aug 30, 2002	TE:		RLD:	Yes
Patent:	⤷ Get Started Free	Patent Expiration:	Feb 6, 2026	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF MUSCULOSKELETAL CONDITIONS

Expired US Patents for NDA 013217

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
King Pharms	SKELAXIN	metaxalone	TABLET;ORAL	013217-003	Aug 30, 2002	⤷ Get Started Free	⤷ Get Started Free
King Pharms	SKELAXIN	metaxalone	TABLET;ORAL	013217-001	Approved Prior to Jan 1, 1982	⤷ Get Started Free	⤷ Get Started Free
King Pharms	SKELAXIN	metaxalone	TABLET;ORAL	013217-003	Aug 30, 2002	⤷ Get Started Free	⤷ Get Started Free
King Pharms	SKELAXIN	metaxalone	TABLET;ORAL	013217-003	Aug 30, 2002	⤷ Get Started Free	⤷ Get Started Free
King Pharms	SKELAXIN	metaxalone	TABLET;ORAL	013217-001	Approved Prior to Jan 1, 1982	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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