Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Northwind Pharmaceuticals, LLC
036986393
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Northwind Pharmaceuticals, LLC
Northwind Pharmaceuticals, LLC
Northwind Pharmaceuticals, LLC
036986393
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Naproxen
Product Details
NDC Product Code
82868-030Application Number
ANDA074140Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 1, 2024POVIDONE K90Inactive
Code: RDH86HJV5ZClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
NaproxenActive
Code: 9TN87S3A3CClass: ACTIBQuantity: 375 mg in 1 1