Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Zydus Pharmaceuticals USA Inc.
156861945
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Zydus Lifesciences Limited
Zydus Pharmaceuticals USA Inc.
Zydus Pharmaceuticals USA Inc.
918596198
Products3
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
68382-012Application Number
ANDA078620Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
November 10, 2022NaproxenActive
Code: 57Y76R9ATQClass: ACTIBQuantity: 250 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
Naproxen
Product Details
NDC Product Code
68382-014Application Number
ANDA078620Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
November 10, 2022NaproxenActive
Code: 57Y76R9ATQClass: ACTIBQuantity: 500 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
Naproxen
Product Details
NDC Product Code
68382-013Application Number
ANDA078620Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
November 10, 2022NaproxenActive
Code: 57Y76R9ATQClass: ACTIBQuantity: 375 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT