Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
PD-Rx Pharmaceuticals, Inc.
156893695
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
PD-Rx Pharmaceuticals, Inc.
PD-Rx Pharmaceuticals, Inc.
PD-Rx Pharmaceuticals, Inc.
156893695
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
72789-003Application Number
ANDA091432Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
September 22, 2023POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8JClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UMClass: IACT
NaproxenActive
Code: 57Y76R9ATQClass: ACTIBQuantity: 500 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT