moxifloxacin Oral Tablet

Brand(s)
Avelox
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Merck Sharp & Dohme Corp. (2016-05-30)
Oldest Current Product
1999-12-10
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL TABLET\MOXIFLOXACIN
FDAOB
ORAL\TABLET\MOXIFLOXACIN HYDROCHLORIDE
SPL Active
ORAL\TABLET, COATED\MOXIFLOXACIN HYDROCHLORIDE
ORAL\TABLET, FILM COATED\MOXIFLOXACIN HYDROCHLORIDE
ORAL\TABLET\MOXIFLOXACIN HYDROCHLORIDE
SPL Moiety
ORAL\TABLET, COATED\MOXIFLOXACIN
ORAL\TABLET, FILM COATED\MOXIFLOXACIN
ORAL\TABLET\MOXIFLOXACIN

product(s) by strength(s)

moxifloxacin 400 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000851733AveloxNDAMerck Sharp & Dohme Corp.1999-12-10MOXIFLOXACIN HYDROCHLORIDEORALTABLET, FILM COATEDNDA02108556b4f979-bf20-4908-9d7c-5536221d77f8

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000937387ANDATeva Pharmaceuticals Usa Inc2014-02-19MOXIFLOXACIN HYDROCHLORIDEORALTABLET, FILM COATEDANDA0774379ee0ccfd-6920-4560-a3b2-6bb88190b0dc
2003782080ANDAMylan Pharmaceuticals Inc.2015-09-23MOXIFLOXACIN HYDROCHLORIDEORALTABLETANDA204635a1d98682-55ac-490f-b2c6-2da6ad2a05ae
3136680201ANDATorrent Pharmaceuticals Limited2014-04-03MOXIFLOXACIN HYDROCHLORIDEORALTABLETANDA200160c3318e0f-e252-4403-a549-498eeb48a0be
4477810268NDA AUTHORIZED GENERICAlvogen, Inc.2014-01-29MOXIFLOXACIN HYDROCHLORIDEORALTABLET, FILM COATEDNDA021085a180872f-69a6-4da9-98ac-f2a368f02896
5551110112ANDADr. Reddy'S Laboratories Ltd2014-03-05MOXIFLOXACIN HYDROCHLORIDEORALTABLET, FILM COATEDANDA07693871b02da1-3175-1db8-192a-c0a8a6cd98a5
6572370156ANDACitron Pharma Llc2014-03-04MOXIFLOXACIN HYDROCHLORIDEORALTABLET, FILM COATEDANDA202632f34c08e6-fe74-4de3-9e36-a82c3c1c183b
7658620603ANDAAurobindo Pharma Limited2014-03-04MOXIFLOXACIN HYDROCHLORIDEORALTABLET, FILM COATEDANDA202632d6789c17-4a2f-4519-9060-e3b0dba422f0

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1009046406ANDAMajor2014-03-05MOXIFLOXACIN HYDROCHLORIDEORALTABLET, FILM COATED551110112ANDA0769387b481eda-7e7a-41b5-b698-bd7d7fa59cfb
2165900881AveloxNDAStat Rx Usa Llc1999-12-10MOXIFLOXACIN HYDROCHLORIDEORALTABLET, FILM COATED000851733NDA0210857d74dfa6-0468-43ad-ad7f-dd90d9ae7706
3430630580NDA AUTHORIZED GENERICPd-Rx Pharmaceuticals, Inc.2014-01-29MOXIFLOXACIN HYDROCHLORIDEORALTABLET, FILM COATED477810268NDA021085c846567e-487e-444d-8649-abed22eba762
4430630585NDA AUTHORIZED GENERICPd-Rx Pharmaceuticals, Inc.2014-01-29MOXIFLOXACIN HYDROCHLORIDEORALTABLET, FILM COATED477810268NDA021085201376ec-bdc8-4db7-a2ac-1fd1680d15d9
5499990455AveloxNDALake Erie Medical Dba Quality Care Products Llc2011-12-07MOXIFLOXACIN HYDROCHLORIDEORALTABLET, COATED000851733NDA021085be8e0025-5726-4965-9510-e7e657687d23
6521250525AveloxNDARemedyrepack Inc.2013-05-24, 2013-07-08MOXIFLOXACIN HYDROCHLORIDEORALTABLET, FILM COATED000851733NDA021085bb42a1cd-1e0d-48a8-bd3e-ff144d38bdea, ebe94683-8fd8-4d99-aa13-46ce14dbcd62
7548684367AveloxNDAPhysicians Total Care, Inc.2009-07-16MOXIFLOXACIN HYDROCHLORIDEORALTABLET, FILM COATED000851733NDA021085222e661d-e956-441a-a02b-b70e0f05c328
8551543516AveloxNDACardinal Health2010-03-02MOXIFLOXACIN HYDROCHLORIDEORALTABLET, FILM COATED000851733NDA0210853a680766-06c8-4643-94c1-0f1bba5cdd8c
9552890077AveloxNDAPd-Rx Pharmaceuticals, Inc.2011-02-25MOXIFLOXACIN HYDROCHLORIDEORALTABLET, FILM COATED000851733NDA02108569deea75-b24f-4d4c-8150-2404a23ef618
10617860360NDA AUTHORIZED GENERICRemedyrepack Inc.2015-06-29MOXIFLOXACIN HYDROCHLORIDEORALTABLET, FILM COATED477810268NDA0210855acc87b0-ad83-4d42-befd-5623e25519aa
11672960154AveloxNDARedpharm Drug Inc.2011-02-25MOXIFLOXACIN HYDROCHLORIDEORALTABLET, FILM COATED000851733NDA021085fe9226f8-64f4-4eff-8339-ed3fce0896f2
12680840722ANDAAmerican Health Packaging2014-03-20MOXIFLOXACIN HYDROCHLORIDEORALTABLET, FILM COATED658620603ANDA2026321ed191f5-7df5-488c-bb72-91ac0b618d9a

application(s)

#idtitleapplicantapprovedpatentapproved drug
1ANDA076938MOXIFLOXACIN HYDROCHLORIDEDR REDDYS LABORATORIES LTD2014-03-04ANDA076938_001
2ANDA077437MOXIFLOXACIN HYDROCHLORIDETEVA PHARMACEUTICALS USA2014-02-18ANDA077437_001
3ANDA200160MOXIFLOXACIN HYDROCHLORIDETORRENT PHARMACEUTICALS LTD2014-04-03ANDA200160_001
4ANDA202632MOXIFLOXACIN HYDROCHLORIDEAUROBINDO PHARMA LTD2014-03-04ANDA202632_001
5ANDA204635MOXIFLOXACIN HYDROCHLORIDEMYLAN PHARMACEUTICALS INC2015-08-31ANDA204635_001
6NDA021085AVELOXBAYER HEALTHCARE PHARMACEUTICALS INC1999-12-10p6610327, METHOD OF COMBATING BACTERIA IN A PATIENT, SUBSTANCE
p5849752, METHOD OF COMBATING BACTERIA IN A PATIENT
NDA021085_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA076938_001RXMOXIFLOXACIN HYDROCHLORIDE (EQ 400MG BASE)ORALTABLETFalseAB2014-03-04MOXIFLOXACIN HYDROCHLORIDE
2ANDA077437_001RXMOXIFLOXACIN HYDROCHLORIDE (EQ 400MG BASE)ORALTABLETFalseAB2014-02-18MOXIFLOXACIN HYDROCHLORIDE
3ANDA200160_001RXMOXIFLOXACIN HYDROCHLORIDE (EQ 400MG BASE)ORALTABLETFalseAB2014-04-03MOXIFLOXACIN HYDROCHLORIDE
4ANDA202632_001RXMOXIFLOXACIN HYDROCHLORIDE (EQ 400MG BASE)ORALTABLETFalseAB2014-03-04MOXIFLOXACIN HYDROCHLORIDE
5ANDA204635_001RXMOXIFLOXACIN HYDROCHLORIDE (EQ 400MG BASE)ORALTABLETFalseAB2015-08-31MOXIFLOXACIN HYDROCHLORIDE
6NDA021085_001RXMOXIFLOXACIN HYDROCHLORIDE (EQ 400MG BASE)ORALTABLETTrueAB1999-12-10AVELOX

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5849752 (view patent)2016-12-05NDA021085, NDA021277moxifloxacin Injection
2p6610327 (view patent)2019-10-29NDA021085

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
11ed191f5-7df5-488c-bb72-91ac0b618d9a (view SPL)These highlights do not include all the information needed to use moxifloxacin hydrochloride tablets safely and effectively. See full prescribing information for moxifloxacin hydrochloride tablets. MOXIFLOXACIN Hydrochloride Tablet, film-coated for oral useInitial U.S. Approval: 1999prescriptionHuman PrescriptionAmerican Health PackagingREPACK2014-03-191680840722
2201376ec-bdc8-4db7-a2ac-1fd1680d15d9 (view SPL)These highlights do not include all the information needed to use MOXIFLOXACIN HYDROCHLORIDE safely and effectively. See full prescribing information for MOXIFLOXACIN HYDROCHLORIDE MOXIFLOXACIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1999prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2015-05-277430630585
3222e661d-e956-441a-a02b-b70e0f05c328 (view SPL)These highlights do not include all the information needed to use AVELOX safely and effectively. See full prescribing information for AVELOX.Initial U.S. Approval: 1999prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2011-12-136548684367
43a680766-06c8-4643-94c1-0f1bba5cdd8c (view SPL)These highlights do not include all the information needed to use AVELOX safely and effectively. See full prescribing information for AVELOX.AVELOX (moxifloxacin hydrochloride) Tablet, film-coatedAVELOX (moxifloxacin hydrochloride) Injection, solution for IV use.Initial U.S. Approval: 1999prescriptionHuman PrescriptionCardinal HealthREPACK2013-04-112551543516
556b4f979-bf20-4908-9d7c-5536221d77f8 (view SPL)These highlights do not include all the information needed to use AVELOX safely and effectively. See full prescribing information for AVELOX AVELOX (moxifloxacin hydrochloride) tablets, for oral useAVELOX (moxifloxacin hydrochloride) injection, for intravenous use Initial U.S. Approval: 1999prescriptionHuman PrescriptionMerck Sharp & Dohme Corp.MANUFACTURE2016-05-3026000851733, 000851737moxifloxacin Injection
65acc87b0-ad83-4d42-befd-5623e25519aa (view SPL)These highlights do not include all the information needed to use MOXIFLOXACIN HYDROCHLORIDE safely and effectively. See full prescribing information for MOXIFLOXACIN HYDROCHLORIDEMOXIFLOXACIN HYDROCHLORIDE tablets, for oral useInitial U.S. Approval: 1999prescriptionHuman PrescriptionRemedyrepack Inc.2015-06-291617860360
769deea75-b24f-4d4c-8150-2404a23ef618 (view SPL)These highlights do not include all the information needed to use AVELOX safely and effectively. See full prescribing information for AVELOX.Initial U.S. Approval: 1999prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2011-10-2016552890077
871b02da1-3175-1db8-192a-c0a8a6cd98a5 (view SPL)These highlights do not include all the information needed to use moxifloxacin safely and effectively. See full prescribing information for moxifloxacin. MOXIFLOXACIN Hydrochloride Tablet, for oral use. Initial U.S. Approval: 1999 To reduce the development of drug-resistant bacteria and maintain the effectiveness of moxifloxacin and other antibacterial drugs, moxifloxacin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.prescriptionHuman PrescriptionDr. Reddy'S Laboratories Ltdanalysis, manufacture2015-01-066551110112
97b481eda-7e7a-41b5-b698-bd7d7fa59cfb (view SPL)These highlights do not include all the information needed to use moxifloxacin safely and effectively. See full prescribing information for moxifloxacin. MOXIFLOXACIN Hydrochloride Tablet, for oral use. Initial U.S. Approval: 1999 To reduce the development of drug-resistant bacteria and maintain the effectiveness of moxifloxacin and other antibacterial drugs, moxifloxacin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.prescriptionHuman PrescriptionMajor2014-04-251009046406
107d74dfa6-0468-43ad-ad7f-dd90d9ae7706 (view SPL)AVELOX (moxifloxacin hydrochloride) tablet, film coatedprescriptionHuman PrescriptionStat Rx Usa Llc2009-10-251165900881
119ee0ccfd-6920-4560-a3b2-6bb88190b0dc (view SPL)These highlights do not include all the information needed to use moxifloxacin hydrochloride tablets safely and effectively. See full prescribing information for moxifloxacin hydrochloride tablets. MOXIFLOXACIN hydrochloride tablets, film-coated, for oral useInitial U.S. Approval: 1999 To reduce the development of drug-resistant bacteria and maintain the effectiveness of moxifloxacin hydrochloride and other antibacterial drugs, moxifloxacin hydrochloride should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.prescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-06-054000937387
12a180872f-69a6-4da9-98ac-f2a368f02896 (view SPL)These highlights do not include all the information needed to use MOXIFLOXACIN HYDROCHLORIDE safely and effectively. See full prescribing information for MOXIFLOXACIN HYDROCHLORIDE MOXIFLOXACIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1999prescriptionHuman PrescriptionAlvogen, Inc.MANUFACTURE2015-05-276477810268
13a1d98682-55ac-490f-b2c6-2da6ad2a05ae (view SPL)These highlights do not include all the information needed to use MOXIFLOXACIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for MOXIFLOXACIN HYDROCHLORIDE TABLETS. MOXIFLOXACIN HYDROCHLORIDE tablets, film-coated, for oral use Initial U.S. Approval: 1999prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2015-08-054003782080
14bb42a1cd-1e0d-48a8-bd3e-ff144d38bdea (view SPL)These highlights do not include all the information needed to use AVELOX safely and effectively. See full prescribing information for AVELOX.AVELOX (moxifloxacin) hydrochloride Tablet, film-coatedAVELOX (moxifloxacin) hydrochloride Injection, solution for IV useInitial U.S. Approval: 1999prescriptionHuman PrescriptionRemedyrepack Inc.2013-05-241521250525
15be8e0025-5726-4965-9510-e7e657687d23 (view SPL)These highlights do not include all the information needed to use AVELOX safely and effectively. See full prescribing information for AVELOX.Initial U.S. Approval: 1999prescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrelabel, repack2011-12-073336499990455
16c3318e0f-e252-4403-a549-498eeb48a0be (view SPL)These highlights do not include all the information needed to use MOXIFLOXACIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for MOXIFLOXACIN HYDROCHLORIDE TABLETS. MOXIFLOXACIN HYDROCHLORIDE tablets, for oral useRx Only Initial U.S. Approval: 1999prescriptionHuman PrescriptionTorrent Pharmaceuticals Limitedmanufacture2015-09-012136680201
17c846567e-487e-444d-8649-abed22eba762 (view SPL)These highlights do not include all the information needed to use MOXIFLOXACIN HYDROCHLORIDE safely and effectively. See full prescribing information for MOXIFLOXACIN HYDROCHLORIDE MOXIFLOXACIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1999prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2015-05-277430630580
18d6789c17-4a2f-4519-9060-e3b0dba422f0 (view SPL)These highlights do not include all the information needed to use moxifloxacin hydrochloride tablets safely and effectively. See full prescribing information for moxifloxacin hydrochloride tablets. MOXIFLOXACIN hydrochloride tablet, film-coated for oral useInitial U.S. Approval: 1999prescriptionHuman PrescriptionAurobindo Pharma LimitedANALYSIS, API MANUFACTURE, MANUFACTURE2014-12-082658620603
19ebe94683-8fd8-4d99-aa13-46ce14dbcd62 (view SPL)These highlights do not include all the information needed to use AVELOX safely and effectively. See full prescribing information for AVELOX.AVELOX (moxifloxacin) hydrochloride Tablet, film-coatedAVELOX (moxifloxacin) hydrochloride Injection, solution for IV useInitial U.S. Approval: 1999prescriptionHuman PrescriptionRemedyrepack Inc.2013-07-081521250525
20f34c08e6-fe74-4de3-9e36-a82c3c1c183b (view SPL)These highlights do not include all the information needed to use moxifloxacin hydrochloride tablets safely and effectively. See full prescribing information for moxifloxacin hydrochloride tablets. MOXIFLOXACIN hydrochloride tablet, film-coated for oral useInitial U.S. Approval: 1999prescriptionHuman PrescriptionCitron Pharma Llc2015-10-231572370156
21fe9226f8-64f4-4eff-8339-ed3fce0896f2 (view SPL)These highlights do not include all the information needed to use AVELOX safely and effectively. See full prescribing information for AVELOX.Initial U.S. Approval: 1999prescriptionHuman PrescriptionRedpharm Drug Inc.MANUFACTURE2011-08-082672960154

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