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ACTIVE SUBSTANCE / INN

NAPROXEN

Brand name(s): NAPROXEN, PREVACID NAPRAPAC 500 (COPACKAGED), NAPROXEN AND ESOMEPRAZOLE MAGNESIUM, NAPROSYN, EC-NAPROSYN, PREVACID NAPRAPAC 375 (COPACKAGED)
FDA LISTED
PRESCRIPTION
DISCONTINUED
NONE (TENTATIVE APPROVAL)
ANDA074936
NDA020067
ACTIVE SUBSTANCE
Naproxen
REGULATORS
FDA
SPONSORS / MAH
AJANTA PHARMA LTD, ATNAHS PHARMA US, DR REDDYS LABS LTD
TOTAL APPLICATIONS
10
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
NAPROXENANDA078620ZYDUS PHARMS USAPrescription
NAPROSYNNDA018965ATNAHS PHARMA USPrescription
NAPROXEN AND ESOMEPRAZOLE MAGNESIUMANDA213699AJANTA PHARMA LTDPrescription
NAPROXENANDA074936ACTAVIS ELIZABETHDiscontinued
NAPROSYNNDA017581ATNAHS PHARMA USDiscontinued
NAPROXEN AND ESOMEPRAZOLE MAGNESIUMANDA202461DR REDDYS LABS LTDNone (Tentative Approval)
NAPROXEN AND ESOMEPRAZOLE MAGNESIUMANDA204470ACTAVIS LABS FL INCDiscontinued
EC-NAPROSYNNDA020067ATNAHS PHARMA USPrescription
PREVACID NAPRAPAC 375 (COPACKAGED)NDA021507TAKEDA PHARMS NADiscontinued
PREVACID NAPRAPAC 500 (COPACKAGED)NDA021507TAKEDA PHARMS NADiscontinued

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