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ACTIVE SUBSTANCE / INN

ESOMEPRAZOLE MAGNESIUM

Brand name(s): ESOMEPRAZOLE MAGNESIUM, NAPROXEN AND ESOMEPRAZOLE MAGNESIUM, NEXIUM, VIMOVO, NEXIUM 24HR
FDA LISTED
PRESCRIPTION
OVER-THE-COUNTER
DISCONTINUED
NDA022101
ANDA207198
ACTIVE SUBSTANCE
Esomeprazole Magnesium
REGULATORS
FDA
SPONSORS / MAH
ASTRAZENECA LP, DR REDDYS, ASTRAZENECA
TOTAL APPLICATIONS
9
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
ESOMEPRAZOLE MAGNESIUMANDA078936MYLANPrescription
ESOMEPRAZOLE MAGNESIUMANDA207265HEC PHARMDiscontinued
NAPROXEN AND ESOMEPRAZOLE MAGNESIUMANDA213699AJANTA PHARMA LTDPrescription
ESOMEPRAZOLE MAGNESIUMANDA207198DR REDDYSOver-the-counter
NEXIUM 24HRNDA204655ASTRAZENECA LPOver-the-counter
NAPROXEN AND ESOMEPRAZOLE MAGNESIUMANDA202461DR REDDYS LABS LTDNone (Tentative Approval)
NEXIUMNDA022101ASTRAZENECAPrescription
NAPROXEN AND ESOMEPRAZOLE MAGNESIUMANDA204470ACTAVIS LABS FL INCDiscontinued
VIMOVONDA022511HORIZONDiscontinued

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