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N020634-001LEVAQUINLEVOFLOXACIN250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-12-20
N020634-002LEVAQUINLEVOFLOXACIN500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-12-20
N020634-003LEVAQUINLEVOFLOXACIN750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-09-08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**Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-12-2084e616aacf4f…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**Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-12-2084e616aacf4f…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**Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-09-0884e616aacf4f…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 3 of 4 · 77 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LevofloxacinLEVOFLOXACINNuCare Pharmaceuticals,Inc.05d179f5-b200-8597-e063-6394a90a10cc2025-03-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINNuCare Pharmaceuticals,Inc.80501b71-2f08-2ef5-e053-2991aa0a6e862025-02-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
levofloxacinLEVOFLOXACINCoupler LLC2cee61b7-be51-0fe5-e063-6294a90af9e32025-01-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
levofloxacinLEVOFLOXACINPreferred Pharmaceuticals Inc067e260c-dc47-4957-a9ff-5a79f17b4ca02025-01-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINDirectRxdabedb15-5b55-3853-e053-2995a90aa44e2025-01-21Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINPD-Rx Pharmaceuticals, Inc.d98cf024-51fa-45a1-b247-da55aba88ca02025-01-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINNuCare Pharmaceuticals,Inc.8423b021-e09c-4f1c-e053-2991aa0afef62025-01-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINADVANCED RX PHARMACY OF TENNESSEE, LLCaf4b7333-4f77-4ec9-e053-2a95a90a16d22024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINAdvanced Rx of Tennessee, LLCafd5cb35-4232-f8b1-e053-2a95a90a8c5b2024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINAdvanced Rx of Tennessee, LLCb001d60e-b8fb-54ff-e053-2a95a90a29702024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINA-S Medication Solutionsbdc8b2cc-a914-4613-ac7c-e8dfe91dea132024-09-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINGolden State Medical Supply, Inc.bfe280be-0789-69fa-e053-2a95a90a0e132024-09-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINBryant Ranch Prepack171ab6c6-8eb5-4716-926f-cee52b7d09682024-09-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
LEVOFLOXACINLEVOFLOXACINGland Pharma Limitedba69722b-d7f2-4519-8a63-9ee91294c4992024-09-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINBryant Ranch Prepack54a02488-586d-4c4e-8a35-68a067bdd6e32024-08-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
levofloxacinLEVOFLOXACINBryant Ranch Prepackb7a614b0-f604-48e1-9919-21da8f939d932024-08-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINBryant Ranch Prepack804ec547-5b89-4fd0-89b3-7445543e563e2024-08-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
levofloxacinLEVOFLOXACINZydus Lifesciences Limitedffa121b8-388f-4d7b-af48-d4aa8d9b59612024-08-16Name fallback
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINCamber Pharmaceuticals, Inc.b43e9b51-568c-4d84-bbd1-d237120056c42024-08-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINNuCare Pharmaceuticals, Inc.4a405103-41e8-6a1f-e054-00144ff8d46c2024-07-19Boxed 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