FDA.reportPublic FDA data

Application 020634

Type
NDA
Sponsor
JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVAQUINLEVOFLOXACINTABLET;ORAL250MGYesNo
002LEVAQUINLEVOFLOXACINTABLET;ORAL500MGYesNo
003LEVAQUINLEVOFLOXACINTABLET;ORAL750MGYesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020634-001LEVAQUINLEVOFLOXACIN250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-12-20
N020634-002LEVAQUINLEVOFLOXACIN500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-12-20
N020634-003LEVAQUINLEVOFLOXACIN750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-09-08

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 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N020634-001LEVAQUIN250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-12-2084e616aacf4f…
2026-09-14 22:38:342026-08N020634-002LEVAQUIN500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-12-2084e616aacf4f…
2026-09-14 22:38:342026-08N020634-003LEVAQUIN750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-09-0884e616aacf4f…
2026-08-18 06:07:402026-07N020634-001LEVAQUIN250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-12-20caaa826d4ba7…
2026-08-18 06:07:402026-07N020634-002LEVAQUIN500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-12-20caaa826d4ba7…
2026-08-18 06:07:402026-07N020634-003LEVAQUIN750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-09-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020634-001LEVAQUIN250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-12-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020634-002LEVAQUIN500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-12-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020634-003LEVAQUIN750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-09-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020634-001LEVAQUIN250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-12-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020634-002LEVAQUIN500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-12-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020634-003LEVAQUIN750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-09-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08N020634-001LEVAQUIN250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-12-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020634-002LEVAQUIN500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-12-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020634-003LEVAQUIN750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-09-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020634-001LEVAQUIN250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-12-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020634-002LEVAQUIN500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-12-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020634-003LEVAQUIN750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-09-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020634-001LEVAQUIN250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-12-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020634-002LEVAQUIN500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-12-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020634-003LEVAQUIN750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-09-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020634-001LEVAQUIN250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-12-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020634-002LEVAQUIN500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-12-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020634-003LEVAQUIN750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-09-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020634-001LEVAQUIN250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-12-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020634-002LEVAQUIN500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-12-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020634-003LEVAQUIN750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-09-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020634-001LEVAQUIN250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-12-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020634-002LEVAQUIN500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-12-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020634-003LEVAQUIN750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-09-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020634-001LEVAQUIN250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-12-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020634-002LEVAQUIN500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-12-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020634-003LEVAQUIN750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-09-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020634-001LEVAQUIN250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-12-20d06236e962d9…
2024-10-29 15:01 UTC2024-10N020634-002LEVAQUIN500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-12-20d06236e962d9…
2024-10-29 15:01 UTC2024-10N020634-003LEVAQUIN750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-09-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020634-001LEVAQUIN250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-12-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020634-002LEVAQUIN500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-12-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020634-003LEVAQUIN750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-09-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020634-001LEVAQUIN250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-12-20301d65b070ca…

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 4 of 4 · 77 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LevofloxacinLEVOFLOXACINLupin Pharmaceuticals, Inc.4be13bd5-0c39-43c3-9232-b1226ccd4dbc2024-07-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINNuCare Pharmaceuticals,Inc.631523e7-7d67-0cc3-e053-2a91aa0abb622024-07-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINGland Pharma Limited95479f18-76dc-41cf-a359-922febeed0f22024-07-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINDr. Reddy's Laboratories Limited9b59428a-a23a-b2d9-982f-98f8a1ed381f2024-06-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
levofloxacinLEVOFLOXACINViona Pharmaceuticals Inc0948bff7-efc6-4f0e-a9dd-adca5bdc7fc22024-06-25Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINAurobindo Pharma Limited529ac72c-c4a0-4001-8cf9-b94f5bf7265c2024-06-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINANI Pharmaceuticals, Inc.a894e40b-77e4-439b-b0f8-9a5cc7a1dd902024-06-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINEugia US LLC4d400bf9-988f-42ec-93f1-e71a93a324b22024-06-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINNuCare Pharmaceuticals,Inc.72cb9372-e9f8-3ca1-e053-2a91aa0ad8202024-06-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINFresenius Kabi USA, LLCeb30fafa-bbb9-458f-89df-ae610fa6aa962024-05-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINAsclemed USA, Inc.2e32a8aa-047b-46c6-b67b-d88a9a0a810b2024-05-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINMacleods Pharmaceuticals Limitedfc165a6d-24b0-4753-a7ac-94a134dca0d32023-01-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINProficient Rx LP95149cfb-1a71-42b7-b50d-9a2e943343392022-09-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINProficient Rx LP30958610-3803-45e6-aa3c-d256decbe6e42019-10-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINHikma Pharmaceuticals USA Inc.e680c759-16c5-4532-9c9c-f42c8c3df74a2019-03-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINHikma Pharmaceuticals USA Inc.f23c0df4-ae2a-446c-a9ba-dbbeb6ffaba52019-03-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINBaxter Healthcare Corporation70c87464-1806-480a-8ebd-3f02987ff4362019-03-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN

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 · 26 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-464LEVAQUINlevofloxacinRebel Distributors CorpNDACurrent
21695-519LEVAQUINlevofloxacinRebel Distributors CorpNDACurrent
43063-113LevaquinlevofloxacinPD-Rx Pharmaceuticals, Inc.NDACurrent
43063-113LevaquinlevofloxacinPD-Rx Pharmaceuticals, Inc.NDACurrent
50458-920LevaquinlevofloxacinJanssen Pharmaceuticals, Inc.NDACurrent
50458-920LevaquinlevofloxacinJanssen Pharmaceuticals, Inc.NDACurrent
50458-920LevaquinlevofloxacinJanssen Pharmaceuticals, Inc.NDACurrent
50458-925LevaquinlevofloxacinJanssen Pharmaceuticals, Inc.NDACurrent
50458-925LevaquinlevofloxacinJanssen Pharmaceuticals, Inc.NDACurrent
50458-925LevaquinlevofloxacinJanssen Pharmaceuticals, Inc.NDACurrent
50458-925LevaquinlevofloxacinJanssen Pharmaceuticals, Inc.NDACurrent
50458-925LevaquinlevofloxacinJanssen Pharmaceuticals, Inc.NDACurrent
50458-925LevaquinlevofloxacinJanssen Pharmaceuticals, Inc.NDACurrent
50458-930LevaquinlevofloxacinJanssen Pharmaceuticals, Inc.NDACurrent
50458-930LevaquinlevofloxacinJanssen Pharmaceuticals, Inc.NDACurrent
50458-930LevaquinlevofloxacinJanssen Pharmaceuticals, Inc.NDACurrent
50458-930LevaquinlevofloxacinJanssen Pharmaceuticals, Inc.NDACurrent
50458-930LevaquinlevofloxacinJanssen Pharmaceuticals, Inc.NDACurrent
50458-930LevaquinlevofloxacinJanssen Pharmaceuticals, Inc.NDACurrent
55289-394LevaquinlevofloxacinPD-Rx Pharmaceuticals, InNDACurrent
55289-394LevaquinlevofloxacinPD-Rx Pharmaceuticals, Inc.NDACurrent
67296-0372LEVAQUINlevofloxacinRedPharm Drug Inc.NDACurrent
67296-0584LEVAQUINlevofloxacinRedPharm Drug Inc.NDACurrent
67296-0586LEVAQUINlevofloxacinRedPharm Drug Inc.NDACurrent
70518-0501LevaquinlevofloxacinREMEDYREPACK INC.NDACurrent
70518-0501LevaquinlevofloxacinREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
63784SUPPL2020-07-02
63783SUPPL2020-07-02
63678SUPPL2020-06-24
59225SUPPL2019-07-02
59224SUPPL2019-07-02
59201SUPPL2019-07-01
58632SUPPL2019-05-08
58574SUPPL2019-05-06
56065SUPPL2018-10-23
56031SUPPL2018-10-19
56030SUPPL2018-10-19
54820SUPPL2018-07-06
54741SUPPL2018-07-03
54740SUPPL2018-07-03
47163SUPPL2017-02-10
47149SUPPL2017-02-09
25383SUPPL2016-07-26
12890SUPPL2016-07-26
41505SUPPL2015-03-11
35017SUPPL2014-05-28
25382SUPPL2014-05-28
25381SUPPL2013-08-16
12889SUPPL2013-08-15
41507SUPPL2012-06-22
41506SUPPL2012-06-22
25379SUPPL2012-05-01
35016SUPPL2012-04-30
25380SUPPL2011-10-13
2940SUPPL2011-10-13
12888SUPPL2011-10-12
12887SUPPL2011-10-12
35015SUPPL2011-06-14
25378SUPPL2011-06-14
12886SUPPL2011-03-04
2939SUPPL2011-03-03
41504SUPPL2009-09-17
41503SUPPL2009-09-17
35014SUPPL2009-05-11
2938SUPPL2009-05-05
25377SUPPL2009-03-13
35013SUPPL2008-10-08
25376SUPPL2008-10-07
41502SUPPL2008-08-01
20784SUPPL2008-08-01
24177SUPPL2008-07-16
12885SUPPL2008-06-05
25374SUPPL2008-05-08
25375SUPPL2008-04-18
2937SUPPL2008-01-09
12884SUPPL2007-12-14
35012SUPPL2007-11-19
12883SUPPL2007-11-19
2936SUPPL2007-11-19
2935SUPPL2007-11-19
25373SUPPL2007-09-25
25372SUPPL2007-09-25
12881SUPPL2007-09-19
12879SUPPL2007-09-19
2934SUPPL2007-07-05
12882SUPPL2007-06-27
12880SUPPL2007-06-04
2932SUPPL2007-06-04
35011SUPPL2007-05-16
2933SUPPL2007-05-16
41499ORIG2007-04-24
35010SUPPL2006-06-28
25371SUPPL2006-06-28
35009SUPPL2006-01-27
35008SUPPL2005-08-08
25370SUPPL2005-08-08
41501SUPPL2005-06-27
20783SUPPL2005-06-27
20782SUPPL2005-06-27
35006SUPPL2004-12-03
2930SUPPL2004-12-02
35007SUPPL2004-11-08
2931SUPPL2004-11-08
35005SUPPL2004-09-15
25369SUPPL2004-09-15
12878SUPPL2004-09-15
2929SUPPL2004-09-15
41500SUPPL2004-09-09
20781SUPPL2004-09-09
35004SUPPL2004-07-21
44455SUPPL2004-06-08
34998SUPPL2004-06-08
35003SUPPL2004-04-05
25368SUPPL2004-03-10
2928SUPPL2003-12-04
35002SUPPL2003-06-08
2927SUPPL2003-06-08
25367SUPPL2002-10-30
35001SUPPL2001-12-18
35000SUPPL2001-12-18
25366SUPPL2001-12-18
25365SUPPL2001-12-18
12877SUPPL2001-12-18
2926SUPPL2001-12-18
34999SUPPL2000-09-08
25364SUPPL2000-09-08