Atovaquone / Proguanil Oral Tablet

Brand(s)
Malarone
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Glaxosmithkline Llc (2014-07-03)
Oldest Current Product
2000-07-26
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL TABLET\ATOVAQUONE:PROGUANIL
FDAOB
ORAL\TABLET\ATOVAQUONE: PROGUANIL HYDROCHLORIDE
SPL Active
ORAL\TABLET, FILM COATED\ATOVAQUONE: PROGUANIL HYDROCHLORIDE
ORAL\TABLET\ATOVAQUONE: PROGUANIL HYDROCHLORIDE
SPL Moiety
ORAL\TABLET, FILM COATED\ATOVAQUONE: PROGUANIL
ORAL\TABLET\ATOVAQUONE: PROGUANIL

product(s) by strength(s)

atovaquone 250 mg / proguanil hydrochloride 100 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001730675MalaroneNDAGlaxosmithkline Llc2000-07-26ATOVAQUONE, PROGUANIL HYDROCHLORIDEORALTABLET, FILM COATEDNDA021078fc22e8d8-3bfb-4f70-a599-dd81262a4887

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003784162ANDAMylan Pharmaceuticals Inc.2014-05-28ATOVAQUONE, PROGUANIL HYDROCHLORIDEORALTABLET, FILM COATEDANDA20236257d74d71-8cf8-4b10-9420-22954fae623c
2669930060NDA AUTHORIZED GENERICPrasco Laboratories2012-07-27ATOVAQUONE, PROGUANIL HYDROCHLORIDEORALTABLET, FILM COATEDNDA0210787069521a-c7f9-4e8d-99b8-0cb5c971e7cf
3680010245ANDABluepoint Laboratories2014-03-13ATOVAQUONE, PROGUANIL HYDROCHLORIDEORALTABLET, FILM COATEDANDA091211ad25ab65-42aa-48f6-b5ed-247f3685d5bf
4684620404ANDAGlenmark Generics Inc., Usa2011-08-18ATOVAQUONE, PROGUANIL HYDROCHLORIDEORALTABLET, FILM COATEDANDA0912114b80d087-eaa7-448f-967e-344de7f16436

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1105440909ANDABlenheim Pharmacal, Inc.2015-03-19ATOVAQUONE, PROGUANIL HYDROCHLORIDEORALTABLET, FILM COATED684620404ANDA09121113eef6e5-4534-3009-e054-00144ff8d46c
2332610900ANDAAidarex Pharmaceuticals Llc2011-08-18ATOVAQUONE, PROGUANIL HYDROCHLORIDEORALTABLET, FILM COATED684620404ANDA091211186ad795-f19a-4df6-8f81-b2028a3da229
3422540150ANDARebel Distributors Corp2011-08-18ATOVAQUONE, PROGUANIL HYDROCHLORIDEORALTABLET684620404ANDA0912110100f9fd-5d4a-4ee6-9c7f-0b60e69e78b8
4430630393ANDAPd-Rx Pharmaceuticals, Inc.2011-08-18ATOVAQUONE, PROGUANIL HYDROCHLORIDEORALTABLET, FILM COATED684620404ANDA091211a79fb027-66a6-47c8-9ee7-ce9367e9ec6e
5430630522NDA AUTHORIZED GENERICPd-Rx Pharmaceuticals, Inc.2012-07-27ATOVAQUONE, PROGUANIL HYDROCHLORIDEORALTABLET, FILM COATED669930060NDA021078dcf43cbd-fc97-4dc1-a258-afad6cf4cabf
6530340404ANDAClinical Solutions2011-08-18ATOVAQUONE, PROGUANIL HYDROCHLORIDEORALTABLET, FILM COATED684620404ANDA091211baa8a3dc-1334-4e1b-a529-61a31f6ced89
7548686393ANDAPhysicians Total Care, Inc.2013-01-23ATOVAQUONE, PROGUANIL HYDROCHLORIDEORALTABLET, FILM COATED684620404ANDA091211c50d51ab-23c2-45cb-8f68-08f3454fb59b
8552890747MalaroneNDAPd-Rx Pharmaceuticals, Inc.2000-07-26ATOVAQUONE, PROGUANIL HYDROCHLORIDEORALTABLET, FILM COATED001730675NDA021078e27bedfd-c181-44f9-a920-19c2f8cab644
9581180404ANDAClinical Solutions Wholesale2011-08-18ATOVAQUONE, PROGUANIL HYDROCHLORIDEORALTABLET, FILM COATED684620404ANDA091211ba5eecee-d4d0-49ba-8f07-9d5e93272032
10636295531NDA AUTHORIZED GENERICBryant Ranch Prepack2012-07-27ATOVAQUONE, PROGUANIL HYDROCHLORIDEORALTABLET, FILM COATED669930060NDA0210787d124c6f-dbdb-48ee-8fd2-9880fdf9d765
11682581104ANDADispensing Solutions, Inc.2011-08-18ATOVAQUONE, PROGUANIL HYDROCHLORIDEORALTABLET, FILM COATED684620404ANDA091211f8659107-ef6b-4142-a4b8-6934aae07f41

atovaquone 62.5 mg / proguanil hydrochloride 25 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001730676MalaroneNDAGlaxosmithkline Llc2000-07-26ATOVAQUONE, PROGUANIL HYDROCHLORIDEORALTABLET, FILM COATEDNDA021078fc22e8d8-3bfb-4f70-a599-dd81262a4887

generic product(s)(s)

#idcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1003784160ANDAMylan Pharmaceuticals Inc.2014-05-28ATOVAQUONE, PROGUANIL HYDROCHLORIDEORALTABLET, FILM COATEDANDA20236257d74d71-8cf8-4b10-9420-22954fae623c
2684620402ANDAGlenmark Generics Inc., Usa2015-04-08ATOVAQUONE, PROGUANIL HYDROCHLORIDEORALTABLET, FILM COATEDANDA0912114b80d087-eaa7-448f-967e-344de7f16436
3684620563NDA AUTHORIZED GENERICGlenmark Generics Inc., Usa2011-09-152017-07-22ATOVAQUONE, PROGUANIL HYDROCHLORIDEORALTABLET, FILM COATEDNDA02107888061724-7578-4f74-b1ab-5ad3519778e2

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA091211ATOVAQUONE AND PROGUANIL HYDROCHLORIDEGLENMARK GENERICS LTD2011-01-12ANDA091211_001, ANDA091211_002
2ANDA202362ATOVAQUONE AND PROGUANIL HYDROCHLORIDEMYLAN PHARMACEUTICALS INC2014-05-27ANDA202362_001, ANDA202362_002
3NDA021078MALARONEGLAXOSMITHKLINE2000-07-14NDA021078_001, NDA021078_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA091211_001RXATOVAQUONE (250MG), PROGUANIL HYDROCHLORIDE (100MG)ORALTABLETFalseAB2011-01-12ATOVAQUONE AND PROGUANIL HYDROCHLORIDE
2ANDA091211_002RXPROGUANIL HYDROCHLORIDE (25MG), ATOVAQUONE (62.5MG)ORALTABLETFalseAB2015-04-06ATOVAQUONE AND PROGUANIL HYDROCHLORIDE
3ANDA202362_001RXATOVAQUONE (62.5MG), PROGUANIL HYDROCHLORIDE (25MG)ORALTABLETFalseAB2014-05-27ATOVAQUONE AND PROGUANIL HYDROCHLORIDE
4ANDA202362_002RXPROGUANIL HYDROCHLORIDE (100MG), ATOVAQUONE (250MG)ORALTABLETFalseAB2014-05-27ATOVAQUONE AND PROGUANIL HYDROCHLORIDE
5NDA021078_001RXPROGUANIL HYDROCHLORIDE (100MG), ATOVAQUONE (250MG)ORALTABLETTrueAB2000-07-14MALARONE
6NDA021078_002RXATOVAQUONE (62.5MG), PROGUANIL HYDROCHLORIDE (25MG)ORALTABLETFalseAB2000-07-14MALARONE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10100f9fd-5d4a-4ee6-9c7f-0b60e69e78b8 (view SPL)Atovaquone and Proguanil Hydrochloride TabletsprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2012-02-091422540150
213eef6e5-4534-3009-e054-00144ff8d46c (view SPL)These highlights do not include all the information needed to use atovaquone and proguanil hydrochloride tablets safely and effectively. See full prescribing information for atovaquone and proguanil hydrochloride tablets. ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLETS, for oral administration Initial U.S. Approval: 2000prescriptionHuman PrescriptionBlenheim Pharmacal, Inc.repack2015-04-171105440909
3186ad795-f19a-4df6-8f81-b2028a3da229 (view SPL)Atovaquone and Proguanil Hydrochloride TabletsprescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2012-09-101332610900
44b80d087-eaa7-448f-967e-344de7f16436 (view SPL)These highlights do not include all the information needed to use atovaquone and proguanil hydrochloride tablets safely and effectively. See full prescribing information for atovaquone and proguanil hydrochloride tablets. ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLETS, for oral administrationATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLETS, for oral administration Initial U.S. Approval: 2000prescriptionHuman PrescriptionGlenmark Generics Inc., UsaANALYSIS, MANUFACTURE2015-05-187684620402, 684620404
557d74d71-8cf8-4b10-9420-22954fae623c (view SPL)These highlights do not include all the information needed to use atovaquone and proguanil hydrochloride tablets safely and effectively. See full prescribing information for atovaquone and proguanil hydrochloride tablets. Atovaquone and Proguanil Hydrochloride TabletsAtovaquone and Proguanil Hydrochloride Pediatric TabletsInitial U.S. Approval: 2000prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2013-03-052003784160, 003784162
67069521a-c7f9-4e8d-99b8-0cb5c971e7cf (view SPL)These highlights do not include all the information needed to use Atovaquone and Proguanil Hydrochloride Tablets safely and effectively. See full prescribing information for Atovaquone and Proguanil Hydrochloride Tablets. Atovaquone and Proguanil Hydrochloride TabletsInitial U.S. Approval: 2000prescriptionHuman PrescriptionPrasco Laboratories2014-09-024669930060
77d124c6f-dbdb-48ee-8fd2-9880fdf9d765 (view SPL)These highlights do not include all the information needed to use Atovaquone and Proguanil Hydrochloride Tablets safely and effectively. See full prescribing information for Atovaquone and Proguanil Hydrochloride Tablets. Atovaquone and Proguanil Hydrochloride TabletsInitial U.S. Approval: 2000prescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2015-03-131000636295531
888061724-7578-4f74-b1ab-5ad3519778e2 (view SPL)Atovaquone and Proguanil Hydrochloride Pediatric TabletsprescriptionHuman PrescriptionGlenmark Generics Inc., Usa2011-12-156684620563
9a79fb027-66a6-47c8-9ee7-ce9367e9ec6e (view SPL)Atovaquone and Proguanil Hydrochloride TabletsprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2012-07-015430630393
10ad25ab65-42aa-48f6-b5ed-247f3685d5bf (view SPL)These highlights do not include all the information needed to use atovaquone and proguanil hydrochloride tablets safely and effectively. See full prescribing information for atovaquone and proguanil hydrochloride tablets.ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLETS, for oral administrationInitial U.S. Approval: 2000prescriptionHuman PrescriptionBluepoint LaboratoriesANALYSIS, MANUFACTURE2015-05-123680010245
11ba5eecee-d4d0-49ba-8f07-9d5e93272032 (view SPL)Atovaquone and Proguanil Hydrochloride TabletsprescriptionHuman PrescriptionClinical Solutions WholesaleRELABEL, REPACK2013-08-062581180404
12baa8a3dc-1334-4e1b-a529-61a31f6ced89 (view SPL)Atovaquone and Proguanil Hydrochloride TabletsprescriptionHuman PrescriptionClinical Solutionsrelabel, repack2013-04-032530340404
13c50d51ab-23c2-45cb-8f68-08f3454fb59b (view SPL)Atovaquone and Proguanil Hydrochloride TabletsprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2013-02-121548686393
14dcf43cbd-fc97-4dc1-a258-afad6cf4cabf (view SPL)Atovaquone and Proguanil Hydrochloride TabletsprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2012-07-306430630522
15e27bedfd-c181-44f9-a920-19c2f8cab644 (view SPL)MALARONE (atovaquone and proguanil hydrochloride)TabletsprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2011-12-1512552890747
16f8659107-ef6b-4142-a4b8-6934aae07f41 (view SPL)Atovaquone and Proguanil Hydrochloride TabletsprescriptionHuman PrescriptionDispensing Solutions, Inc.relabel, repack2013-08-231682581104
17fc22e8d8-3bfb-4f70-a599-dd81262a4887 (view SPL)These highlights do not include all the information needed to use MALARONE safely and effectively. See full prescribing information for MALARONE.MALARONE (atovaquone and proguanil hydrochloride) TabletsMALARONE (atovaquone and proguanil hydrochloride) Pediatric Tablets Initial U.S. Approval: 2000prescriptionHuman PrescriptionGlaxosmithkline Llc2014-07-0316001730675, 001730676

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