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ACTIVE SUBSTANCE / INN

FAMOTIDINE

Brand name(s): FAMOTIDINE, PEPCID, PEPCID AC, FAMOTIDINE PRESERVATIVE FREE, PEPCID COMPLETE, FLUXID, IBUPROFEN AND FAMOTIDINE
FDA LISTED
PRESCRIPTION
OVER-THE-COUNTER
DISCONTINUED
ANDA075799
ANDA075192
ACTIVE SUBSTANCE
Famotidine
REGULATORS
FDA
SPONSORS / MAH
MYLAN LABS LTD, GLENMARK PHARMS INC, PH HEALTH
TOTAL APPLICATIONS
10
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
FAMOTIDINEANDA077146GLENMARK PHARMS INCOver-the-counter
IBUPROFEN AND FAMOTIDINEANDA203658PH HEALTHPrescription
PEPCID ACNDA020325KENVUE BRANDSOver-the-counter
FAMOTIDINEANDA217137CARNEGIEPrescription
FAMOTIDINEANDA075799HIKMADiscontinued
FAMOTIDINE PRESERVATIVE FREEANDA078642MYLAN LABS LTDPrescription
PEPCIDNDA019527SALIX PHARMSDiscontinued
PEPCID COMPLETENDA020958KENVUE BRANDSOver-the-counter
FLUXIDNDA021712UCB INCDiscontinued
FAMOTIDINEANDA075192MARSAM PHARMS LLCNone (Tentative Approval)

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