Atovaquone Oral Suspension

Brand(s)
Mepron
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Glaxosmithkline Llc (2015-06-04)
Oldest Current Product
1998-09-18
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL SUSPENSION\ATOVAQUONE
FDAOB
ORAL\SUSPENSION\ATOVAQUONE
SPL Active
ORAL\SUSPENSION\ATOVAQUONE
SPL Moiety
ORAL\SUSPENSION\ATOVAQUONE

product(s) by strength(s)

atovaquone 150 mg/ml oral suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001730547MepronNDAGlaxosmithkline Llc1998-09-18ATOVAQUONEORALSUSPENSIONNDA020500b426b6bf-f07e-4580-97ae-dfca1ddf5b8f

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1651620693ANDAAmneal Pharmaceuticals2011-12-09ATOVAQUONEORALSUSPENSIONANDA202960b7398fcf-522a-488a-8dd6-051561f62804
2669930062NDA AUTHORIZED GENERICPrasco Laboratories2014-03-20ATOVAQUONEORALSUSPENSIONNDA02050055eb29e3-6c28-4274-8330-9ace09f6659e

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1551541133MepronNDACardinal Health1998-09-18ATOVAQUONEORALSUSPENSION001730547NDA020500697948e4-9807-4dc0-acc9-b9a3b5fa2f12

application(s)

#idtitleapplicantapprovedpatentapproved drug
1ANDA202960ATOVAQUONEAMNEAL PHARMACEUTICALS2014-03-18ANDA202960_001
2NDA020500MEPRONGLAXOSMITHKLINE LLC1995-02-08p6649659, TREATMENT OF PNEUMOCYSTIS CARINII INFECTIONS, SUBSTANCENDA020500_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA202960_001RXATOVAQUONE (750MG/5ML)ORALSUSPENSIONFalseAB2014-03-18ATOVAQUONE
2NDA020500_001RXATOVAQUONE (750MG/5ML)ORALSUSPENSIONTrueAB1995-02-08MEPRON

patent(s)

#idexpiration dateapplication(s)
1p6649659 (view patent)2016-07-10NDA020500

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
155eb29e3-6c28-4274-8330-9ace09f6659e (view SPL)Atovaquone SuspensionprescriptionHuman PrescriptionPrasco Laboratories2014-03-263669930062
2697948e4-9807-4dc0-acc9-b9a3b5fa2f12 (view SPL)MEPRON (atovaquone)SuspensionprescriptionHuman PrescriptionCardinal HealthREPACK2012-05-162551541133
3b426b6bf-f07e-4580-97ae-dfca1ddf5b8f (view SPL)These highlights do not include all the information needed to use MEPRON suspension safely and effectively. See full prescribing information for MEPRON suspension.MEPRON (atovaquone) oral suspensionInitial U.S. Approval: 1992prescriptionHuman PrescriptionGlaxosmithkline Llc2015-06-0411001730547, 001730665
4b7398fcf-522a-488a-8dd6-051561f62804 (view SPL)These highlights do not include all the information needed to useatovaquone oral suspension safely and effectively. See full prescribing information for atovaquone oral suspension. ATOVAQUONE oral suspension, USP Initial U.S. Approval: 1992prescriptionHuman PrescriptionAmneal PharmaceuticalsANALYSIS, LABEL, MANUFACTURE, PACK2015-07-319651620693

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII