N022503 Metaxalone 640mg Tablet, Primus Pharmaceuticals
Summary
FDA Orange Book listing for NDA 022503 for Metaxalone 640mg oral tablet, approved June 1, 2015, held by Primus Pharmaceuticals Inc. The product is designated as both Reference Listed Drug and Reference Standard, indicating it serves as the comparator product for generic drug approval applications. Marketing status is Prescription only.
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GovPing monitors FDA Orange Book — New Patent Listings for new healthcare & life sciences regulatory changes. Every update since tracking began is archived, classified, and available as free RSS or email alerts — 3 changes logged to date.
What changed
FDA Orange Book added NDA 022503 for Metaxalone 640mg tablet, an oral muscle relaxant, approved June 1, 2015 for Primus Pharmaceuticals Inc. The product carries Reference Listed Drug and Reference Standard designations, meaning it serves as the branded comparator for Abbreviated New Drug Applications (ANDAs). Generic manufacturers seeking approval of metaxalone products must demonstrate bioequivalence to this reference standard.
Affected parties include Primus Pharmaceuticals as the NDA holder, and any generic manufacturers planning ANDA submissions for metaxalone products who must reference this NDA as their listed drug. Orange Book users should monitor this listing for associated patent and exclusivity information.
Archived snapshot
Apr 23, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
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Product Details for NDA 022503
METAXALONE (METAXALONE)
640MG
Marketing Status:
Prescription Active Ingredient: METAXALONE
Proprietary Name: METAXALONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 640MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N022503
Product Number: 001
Approval Date: Jun 1, 2015
Applicant Holder Full Name: PRIMUS PHARMACEUTICALS INC
Marketing Status: Prescription
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