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ACTIVE SUBSTANCE / INN

LANSOPRAZOLE

Brand name(s): PREVACID NAPRAPAC 500 (COPACKAGED), PREVACID IV, LANSOPRAZOLE, PREVPAC (COPACKAGED), PREVACID, LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED), PREVACID NAPRAPAC 375 (COPACKAGED)
FDA LISTED
PRESCRIPTION
OVER-THE-COUNTER
DISCONTINUED
NDA050757
ANDA206006
ACTIVE SUBSTANCE
Lansoprazole
REGULATORS
FDA
SPONSORS / MAH
TAKEDA PHARMS USA, KRKA TOVARNA ZDRAVIL, DR REDDYS LABS LTD
TOTAL APPLICATIONS
10
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
LANSOPRAZOLEANDA091269DR REDDYS LABS LTDPrescription
LANSOPRAZOLEANDA202194DR REDDYS LABS LTDOver-the-counter
LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)ANDA206006RISINGPrescription
PREVPAC (COPACKAGED)NDA050757TAKEDA PHARMS USADiscontinued
PREVACIDNDA021281TAKEDA PHARMS NADiscontinued
LANSOPRAZOLEANDA091212KRKA TOVARNA ZDRAVILDiscontinued
PREVACID IVNDA021566TAKEDA PHARMS NADiscontinued
PREVACIDNDA021428TAKEDA PHARMS USAPrescription
PREVACID NAPRAPAC 375 (COPACKAGED)NDA021507TAKEDA PHARMS NADiscontinued
PREVACID NAPRAPAC 500 (COPACKAGED)NDA021507TAKEDA PHARMS NADiscontinued

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