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ACTIVE SUBSTANCE / INN

CAFFEINE

Brand name(s): FEMCET, EXCEDRIN (MIGRAINE RELIEF), PROPOXYPHENE COMPOUND 65, BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE, ERGOTAMINE TARTRATE AND CAFFEINE, INVAGESIC, Peyona (previously Nymusa), INVAGESIC FORTE
FDA LISTED
EMA LISTED
PRESCRIPTION
OVER-THE-COUNTER
DISCONTINUED
ANDA083077
ANDA075231
ACTIVE SUBSTANCE
Caffeine
REGULATORS
FDA · EMA
SPONSORS / MAH
WATSON LABS, MALLINCKRODT, IVAX SUB TEVA PHARMS
TOTAL APPLICATIONS
11
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
PROPOXYPHENE COMPOUND 65ANDA083077IVAX SUB TEVA PHARMSDiscontinued
FEMCETANDA089102MALLINCKRODTDiscontinued
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEANDA210817DR REDDYS LABS SAPrescription
EXCEDRIN (MIGRAINE RELIEF)NDA020802HALEON US HOLDINGSOver-the-counter
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEANDA040267WATSON LABSDiscontinued
ERGOTAMINE TARTRATE AND CAFFEINEANDA040590ANDA REPOSITORYPrescription
INVAGESICANDA074817CHARTWELL RXDiscontinued
INVAGESIC FORTEANDA074817CHARTWELL RXDiscontinued
BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATEANDA075231LGM PHARMAPrescription
BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATEANDA075351NOVITIUM PHARMADiscontinued
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
Peyona (previously Nymusa)Chiesi Farmaceutici SpAAuthorised02/07/2009Apnea

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