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ACTIVE SUBSTANCE / INN

IBUPROFEN

Brand name(s): IBUPROFEN, MOTRIN, MOTRIN IB, IBUPROFEN AND DIPHENHYDRAMINE CITRATE, Ibuprofen Gen.Orph, NUPRIN, MOTRIN MIGRAINE PAIN, OXYCODONE HYDROCHLORIDE AND IBUPROFEN, COMBOGESIC, IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE, Pedea, IBUPROFEN AND FAMOTIDINE
FDA LISTED
EMA LISTED
PRESCRIPTION
OVER-THE-COUNTER
DISCONTINUED
Ductus Arteriosus, Patent
NDA019012
ACTIVE SUBSTANCE
Ibuprofen
REGULATORS
FDA · EMA
SPONSORS / MAH
PERRIGO, BARR LABS INC, PLD ACQUISITIONS LLC
TOTAL APPLICATIONS
12
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDEANDA076478PERRIGODiscontinued
MOTRINNDA017463MCNEIL CONSUMERDiscontinued
OXYCODONE HYDROCHLORIDE AND IBUPROFENANDA078316BARR LABS INCDiscontinued
MOTRIN MIGRAINE PAINNDA019012KENVUE BRANDSDiscontinued
NUPRINNDA019012KENVUE BRANDSDiscontinued
MOTRIN IBNDA019012KENVUE BRANDSOver-the-counter
IBUPROFEN AND FAMOTIDINEANDA203658PH HEALTHPrescription
COMBOGESICNDA209471AFT PHARMS USPrescription
IBUPROFEN AND DIPHENHYDRAMINE CITRATEANDA211404PLD ACQUISITIONS LLCOver-the-counter
IBUPROFENANDA211666STRIDES PHARMAOver-the-counter
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
Ibuprofen Gen.OrphGen.OrphAuthorised16/02/2024Ductus Arteriosus, Patent
PedeaRecordati Rare DiseasesAuthorised28/07/2004Ductus Arteriosus, Patent

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