FDA.reportPublic FDA data

Application 021085

Type
NDA
Sponsor
BAYER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AVELOXMOXIFLOXACIN HYDROCHLORIDETABLET;ORALEQ 400MG BASEYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021085-001AVELOXMOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-10

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N021085-001AVELOXEQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-10f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021085-001AVELOXEQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-10e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021085-001AVELOXEQ 400MG BASETABLET / ORALRLD1999-12-10cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021085-001AVELOXEQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-10a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12N021085-001AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12N021085-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N021085-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N021085-001AB1ea99ee380514…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021085-00166103272019-10-29U-298Drug product74a2ff9319b5…
2019-12-14 00:12 UTC2019-12N021085-00166103272019-10-29U-298Drug product3f01610625f2…
2019-09-15 20:21 UTC2019-09N021085-00166103272019-10-29U-298Drug productb00525d2431f…
2019-07-19 19:46 UTC2019-07N021085-00166103272019-10-29U-298Drug productea99ee380514…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12N021085-001M-1852019-09-2774a2ff9319b5…
2019-12-14 00:12 UTC2019-12N021085-001M-1852019-09-273f01610625f2…
2019-09-15 20:21 UTC2019-09N021085-001M-1852019-09-27b00525d2431f…
2019-07-19 19:46 UTC2019-07N021085-001M-1852019-09-27ea99ee380514…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 2 · 24 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Moxifloxacin HydrochlorideMOXIFLOXACIN HYDROCHLORIDEAmerican Health Packaging1ed191f5-7df5-488c-bb72-91ac0b618d9a2026-07-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MOXIFLOXACIN HYDROCHLORIDE
MOXIFLOXACIN HYDROCHLORIDEMOXIFLOXACIN HYDROCHLORIDEREMEDYREPACK INC.bd0c0690-ba48-41c5-b76b-b1a53c36f4242026-05-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MOXIFLOXACIN HYDROCHLORIDE
Moxifloxacin HydrochlorideMOXIFLOXACIN HYDROCHLORIDERedpharm Drug51d45346-5506-d2c9-e063-6394a90ae6bb2026-05-15Warnings, Adverse reactionsName fallback
generic name: MOXIFLOXACIN HYDROCHLORIDE
Moxifloxacin HydrochlorideMOXIFLOXACIN HYDROCHLORIDEAvPAK371ca7b2-c62d-ef4b-3076-890b385bfff82026-04-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MOXIFLOXACIN HYDROCHLORIDE
MOXIFLOXACIN HYDROCHLORIDEMOXIFLOXACIN HYDROCHLORIDEMylan Institutional LLCc6fa4129-2f92-4179-ac5d-bb7b4a5387892026-03-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MOXIFLOXACIN HYDROCHLORIDE
Moxifloxacin HydrochlorideMOXIFLOXACIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.be5b7a6f-9ee3-4453-807e-4761fffff60c2026-02-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MOXIFLOXACIN HYDROCHLORIDE
MOXIFLOXACIN HYDROCHLORIDEMOXIFLOXACIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.1a98b20d-c4a1-4184-8387-a4866d1d62bf2026-02-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MOXIFLOXACIN HYDROCHLORIDE
MOXIFLOXACIN HYDROCHLORIDEMOXIFLOXACIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.18b77b31-baf3-416f-b3b7-a631c8e46d202026-02-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MOXIFLOXACIN HYDROCHLORIDE
MOXIFLOXACIN HYDROCHLORIDEMOXIFLOXACIN HYDROCHLORIDEBryant Ranch Prepack6cd420c3-113e-4fc2-b59f-bfc7c485c14d2026-02-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MOXIFLOXACIN HYDROCHLORIDE
VIGAMOXMOXIFLOXACIN HYDROCHLORIDEHarrow Eye, LLC12053b08-7e66-c6f3-e063-6394a90a9cd92026-01-22Warnings, Adverse reactionsName fallback
generic name: MOXIFLOXACIN HYDROCHLORIDE
MOXIFLOXACIN HYDROCHLORIDEMOXIFLOXACIN HYDROCHLORIDEMajor Pharmaceuticals815d71cf-02de-4190-9bd1-3fdc67ef0f062025-12-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MOXIFLOXACIN HYDROCHLORIDE
Moxifloxacin HydrochlorideMOXIFLOXACIN HYDROCHLORIDEBryant Ranch Prepackac8a81b9-2fed-412a-8c83-db8dee1061f62025-10-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MOXIFLOXACIN HYDROCHLORIDE
Moxifloxacin HydrochlorideMOXIFLOXACIN HYDROCHLORIDERising Pharma Holdings, Inc.f34c08e6-fe74-4de3-9e36-a82c3c1c183b2025-10-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MOXIFLOXACIN HYDROCHLORIDE
Moxifloxacin HydrochlorideMOXIFLOXACIN HYDROCHLORIDEA-S Medication Solutions37466c79-8726-4fd6-9412-0bb83d523fe32025-10-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MOXIFLOXACIN HYDROCHLORIDE
MoxifloxacinMOXIFLOXACIN HYDROCHLORIDESolaris Pharma Corporation45ce14e5-98b8-296b-e063-6294a90a769b2025-09-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MOXIFLOXACIN HYDROCHLORIDE
MOXIFLOXACIN HYDROCHLORIDEMOXIFLOXACIN HYDROCHLORIDEAurobindo Pharma Limitedd6789c17-4a2f-4519-9060-e3b0dba422f02025-09-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MOXIFLOXACIN HYDROCHLORIDE
Moxifloxacin HydrochlorideMOXIFLOXACIN HYDROCHLORIDEAsclemed USA, Inc.8f92f110-32d6-4d0c-a415-7a9a4cafb9b82025-04-19Warnings, Adverse reactionsName fallback
generic name: MOXIFLOXACIN HYDROCHLORIDE
Moxifloxacin HydrochlorideMOXIFLOXACIN HYDROCHLORIDESomerset Therapeutics, LLCf7c68d49-8c61-4bde-a880-4d78568e5aa02024-11-25Warnings, Adverse reactionsName fallback
generic name: MOXIFLOXACIN HYDROCHLORIDE
MOXIFLOXACIN HYDROCHLORIDEMOXIFLOXACIN HYDROCHLORIDEA-S Medication Solutions02c29e8e-8346-4e28-b7fc-2f4cb61ad37d2024-09-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MOXIFLOXACIN HYDROCHLORIDE
MoxifloxacinMOXIFLOXACIN HYDROCHLORIDEHp Halden Pharma AS6067b2ee-2171-49bb-aa07-1d401ebf4f2e2024-07-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MOXIFLOXACIN HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0085-1733Aveloxmoxifloxacin hydrochlorideSchering Plough CorporationNDACurrent
43063-580Moxifloxacin Hydrochloridemoxifloxacin hydrochloridePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
43063-580Moxifloxacin Hydrochloridemoxifloxacin hydrochloridePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
43063-580Moxifloxacin Hydrochloridemoxifloxacin hydrochloridePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
43063-585Moxifloxacin Hydrochloridemoxifloxacin hydrochloridePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
47781-268Moxifloxacin Hydrochloridemoxifloxacin hydrochlorideAlvogen, Inc.NDA AUTHORIZED GENERICCurrent
50419-530Aveloxmoxifloxacin hydrochlorideBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-530Aveloxmoxifloxacin hydrochlorideBayer HealthCare Pharmaceuticals Inc.NDACurrent
67296-0154Aveloxmoxifloxacin hydrochlorideRedPharm Drug Inc.NDACurrent
67296-1299Moxifloxacin HydrochlorideMoxifloxacin HydrochlorideRedPharm Drug, Inc.NDA AUTHORIZED GENERICCurrent
67296-1299Moxifloxacin HydrochlorideMoxifloxacin HydrochlorideRedPharm Drug, Inc.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82858SUPPL 2025-07-14
82857SUPPL 2025-07-14
82826SUPPL 2025-07-14
62848SUPPL2020-05-07
62844SUPPL2020-05-07
62847SUPPL2020-05-06
58619SUPPL2019-05-08
58618SUPPL2019-05-08
58571SUPPL2019-05-06
56066SUPPL2018-10-23
56033SUPPL2018-10-19
45433SUPPL2016-09-30
45432SUPPL2016-09-30
45431SUPPL2016-09-30
45430SUPPL2016-09-30
26716SUPPL2016-07-26
14348SUPPL2016-07-26
36079SUPPL2015-06-05
26715SUPPL2015-05-13
36078SUPPL2014-12-03
26714SUPPL2014-11-24
26713SUPPL2013-08-16
14347SUPPL2013-08-15
26712SUPPL2012-12-26
36077SUPPL2012-12-21
36076SUPPL2012-09-11
4282SUPPL2012-08-28
26711SUPPL2011-10-20
14346SUPPL2011-10-20
14345SUPPL2011-10-20
4281SUPPL2011-10-20
26710SUPPL2011-08-08
36075SUPPL2011-03-04
4280SUPPL2011-03-02
4278SUPPL2010-11-02
14343SUPPL2010-10-25
4279SUPPL2010-04-09
36074SUPPL2010-03-05
26709SUPPL2010-01-25
14344SUPPL2009-12-02
4277SUPPL2009-06-29
14342SUPPL2009-05-15
26708SUPPL2009-05-05
36072SUPPL2009-01-02
26707SUPPL2008-12-31
36073SUPPL2008-10-09
4276SUPPL2008-10-07
14341SUPPL2008-02-25
4275SUPPL2008-02-20
21432SUPPL2008-02-19
36071SUPPL2007-06-04
4274SUPPL2007-06-04
14340SUPPL2005-11-30
14339SUPPL2005-11-30
4273SUPPL2005-11-30
4272SUPPL2005-11-30
36070SUPPL2005-06-14
4271SUPPL2005-06-14
14338SUPPL2004-07-30
4270SUPPL2004-07-30
41939ORIG2004-05-27
21431SUPPL2004-05-27
14336SUPPL2004-05-27
4268SUPPL2004-05-26
14337SUPPL2004-04-05
4269SUPPL2004-03-10
36069SUPPL2003-10-10
26706SUPPL2003-10-06
26705SUPPL2003-03-10
26704SUPPL2003-03-10
4267SUPPL2003-03-10
36068SUPPL2003-02-28
36067SUPPL2003-02-28
14335SUPPL2003-02-28
36064SUPPL2002-06-12
36063SUPPL2002-06-12
26701SUPPL2002-06-12
4266SUPPL2002-06-12
36066SUPPL2002-05-16
26703SUPPL2002-05-16
36065SUPPL2001-04-27
26702SUPPL2001-04-27
36062ORIG1999-12-10
26700ORIG1999-12-10
51387ORIG1900-01-01
51386ORIG1900-01-01
51385ORIG1900-01-01