Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Cipla USA Inc.
078719707
Manufacturing Establishments2
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
InvaGen Pharmaceutical Inc
Cipla USA Inc.
Cipla USA Inc.
165104469
InvaGen Pharmaceuticals Inc.
Cipla USA Inc.
Cipla USA Inc.
080334903
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
69097-853Application Number
ANDA091305Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 20, 2019NaproxenActive
Code: 57Y76R9ATQClass: ACTIBQuantity: 250 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
naproxen
Product Details
NDC Product Code
69097-855Application Number
ANDA091305Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 20, 2019NaproxenActive
Code: 57Y76R9ATQClass: ACTIBQuantity: 500 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
naproxen
Product Details
NDC Product Code
69097-854Application Number
ANDA091305Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 20, 2019SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
NaproxenActive
Code: 57Y76R9ATQClass: ACTIBQuantity: 375 mg in 1 1