Mefloquine Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Sandoz Inc (2015-02-10)
Oldest Current Product
2002-02-20
License(s)
ANDA
RxNORM
ORAL TABLET\MEFLOQUINE
FDAOB
ORAL\TABLET\MEFLOQUINE HYDROCHLORIDE
SPL Active
ORAL\TABLET\MEFLOQUINE HYDROCHLORIDE
SPL Moiety
ORAL\TABLET\MEFLOQUINE

product(s) by strength(s)

mefloquine hydrochloride 250 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1000540025ANDARoxane Laboratories, Inc2004-10-01MEFLOQUINE HYDROCHLORIDEORALTABLETANDA07652343fde257-36ee-49ea-a03c-01a1a4e1da3d
2005550171ANDABarr Laboratories Inc.2004-01-06MEFLOQUINE HYDROCHLORIDEORALTABLETANDA07639209716a24-d7da-42b2-af29-c03a1b6670bd
3007815076ANDASandoz Inc2002-02-202016-03-31MEFLOQUINE HYDROCHLORIDEORALTABLETANDA07617505b557b5-24ea-48c7-9ba8-f7d696c86a94

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1001431282ANDAWest-Ward Pharmaceutical Corp2010-04-21MEFLOQUINE HYDROCHLORIDEORALTABLETANDA077699e513d4f7-2eb3-4eaf-ab5b-a835252b0ae6
2216950561ANDARebel Distributors Corp2010-04-21MEFLOQUINE HYDROCHLORIDEORALTABLET001431282ANDA077699b6ccbb82-3804-4f02-bf17-f07e22a8b02a
3529590803ANDAH.J. Harkins Company, Inc.2010-04-21MEFLOQUINE HYDROCHLORIDEORALTABLET001431282ANDA077699e4ed49c5-2a8b-4d2b-b8fb-a69a556a48cc

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950449ANDARebel Distributors Corp2003-12-29MEFLOQUINE HYDROCHLORIDEORALTABLET005550171ANDA07639257ca7bc4-e1a4-4a09-82bd-8b455e5ec3e4
2548685434ANDAPhysicians Total Care, Inc.2005-09-26MEFLOQUINE HYDROCHLORIDEORALTABLET007815076ANDA0761751c47fd79-c0ca-42d6-9910-774272b25bc1

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA076175MEFLOQUINE HYDROCHLORIDESANDOZ INC2002-02-20ANDA076175_001
2ANDA076392MEFLOQUINE HYDROCHLORIDEBARR LABORATORIES INC2003-12-29ANDA076392_001
3ANDA076523MEFLOQUINE HYDROCHLORIDEROXANE LABORATORIES INC2004-10-01ANDA076523_001
4ANDA077699MEFLOQUINE HYDROCHLORIDETrueHIKMA PHARMACEUTICALS LLC2010-04-21ANDA077699_001
5NDA019578MEFLOQUINE HYDROCHLORIDETrueUNITED STATES ARMY WALTER REED ARMY INSTITUTE RESEARCH1989-05-02NDA019578_001
6NDA019591LARIAMTrueHOFFMANN LA ROCHE INC1989-05-02NDA019591_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA076175_001RXMEFLOQUINE HYDROCHLORIDE (250MG)ORALTABLETTrueAB2002-02-20MEFLOQUINE HYDROCHLORIDE
2ANDA076392_001RXMEFLOQUINE HYDROCHLORIDE (250MG)ORALTABLETFalseAB2003-12-29MEFLOQUINE HYDROCHLORIDE
3ANDA076523_001RXMEFLOQUINE HYDROCHLORIDE (250MG)ORALTABLETFalseAB2004-10-01MEFLOQUINE HYDROCHLORIDE
4ANDA077699_001discontinuedMEFLOQUINE HYDROCHLORIDE (250MG)ORALTABLETFalse2010-04-21MEFLOQUINE HYDROCHLORIDE
5NDA019578_001discontinuedMEFLOQUINE HYDROCHLORIDE (250MG)ORALTABLETFalse1989-05-02MEFLOQUINE HYDROCHLORIDE
6NDA019591_001discontinuedMEFLOQUINE HYDROCHLORIDE (250MG)ORALTABLETFalse1989-05-02LARIAM

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
105b557b5-24ea-48c7-9ba8-f7d696c86a94 (view SPL)Mefloquine Hydrochloride Tablets, USPprescriptionHuman PrescriptionSandoz Inc2015-02-1015007815076
209716a24-d7da-42b2-af29-c03a1b6670bd (view SPL)MEFLOQUINE HYDROCHLORIDE TABLETS USPprescriptionHuman PrescriptionBarr Laboratories Inc.2013-07-015005550171
31c47fd79-c0ca-42d6-9910-774272b25bc1 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-01-121548685434
443fde257-36ee-49ea-a03c-01a1a4e1da3d (view SPL)MEFLOQUINE HYDROCHLORIDE Tablets USPprescriptionHuman PrescriptionRoxane Laboratories, IncAPI MANUFACTURE, MANUFACTURE2013-06-147000540025
557ca7bc4-e1a4-4a09-82bd-8b455e5ec3e4 (view SPL)MEFLOQUINE HYDROCHLORIDE TABLETSprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-12-282216950449
6b6ccbb82-3804-4f02-bf17-f07e22a8b02a (view SPL)Mefloquine Hydrochloride TabletsRev. 07/11prescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2012-02-091216950561
7e4ed49c5-2a8b-4d2b-b8fb-a69a556a48cc (view SPL)Mefloquine Hydrochloride TabletsRev. 07/11prescriptionHuman PrescriptionH.J. Harkins Company, Inc.MANUFACTURE2012-02-161529590803
8e513d4f7-2eb3-4eaf-ab5b-a835252b0ae6 (view SPL)Mefloquine Hydrochloride TabletsRev. 07/11prescriptionHuman PrescriptionWest-Ward Pharmaceutical CorpMANUFACTURE2011-08-053001431282

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