Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Northwind Pharmaceuticals
036986393
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Northwind Pharmaceuticals
Northwind Pharmaceuticals
Northwind Pharmaceuticals
036986393
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Metaxalone
Product Details
NDC Product Code
51655-162Application Number
ANDA203399Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
June 17, 2014MetaxaloneActive
Code: 1NMA9J598YClass: ACTIBQuantity: 800 mg in 1 1