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Last Updated: April 13, 2024

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-three 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
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength800MG
Approval Date:Aug 30, 2002TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Feb 6, 2026Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF MUSCULOSKELETAL CONDITIONS

Expired US Patents for NDA 013217

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

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