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N020634-001LEVAQUINLEVOFLOXACIN250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-12-20
N020634-002LEVAQUINLEVOFLOXACIN500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-12-20
N020634-003LEVAQUINLEVOFLOXACIN750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-09-08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**Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-12-2084e616aacf4f…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**Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-12-2084e616aacf4f…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**Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-09-0884e616aacf4f…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 2 of 4 · 77 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LevofloxacinLEVOFLOXACINREMEDYREPACK INC.b8ac5047-5203-42c4-886b-dd0b08a1786f2026-01-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINREMEDYREPACK INC.16d51c1c-4144-4be7-9356-98fcee621ecd2026-01-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINNorthwind Health Company, LLCf2f090c2-3ee1-7689-e053-2995a90abe382026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINNorthwind Health Company, LLCf780bb91-483a-d1a6-e053-6294a90ab74b2026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINNorthwind Health Company, LLCf33140d5-59ad-3379-e053-2995a90ae2862026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINBPI LABS LLCb6d9740b-2f9d-4f1c-bc9b-4c2150b22f102025-12-26Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
levofloxacinLEVOFLOXACINRedpharm Drug301ecffc-ecaf-01de-e063-6294a90a61b32025-12-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINST. MARY'S MEDICAL PARK PHARMACY46a3c619-b2a3-3f28-e063-6394a90a23092025-12-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINNuCare Pharmaceuticals,Inc.c6027cde-b9fe-e593-e053-2995a90ac2c12025-12-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINHospira, Inc5a1534af-aa1c-4f1d-ba9f-9415b14e1af22025-11-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINVERITYRX, LLC427a2077-5dbb-3c5e-e063-6294a90a08392025-10-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINPD-Rx Pharmaceuticals, Inc.814450ae-439e-4a5d-8c60-9b21b6f14be52025-10-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINPD-Rx Pharmaceuticals, Inc.b1a4aabb-42af-4133-8e82-0c7ec8fa79c32025-10-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINPD-Rx Pharmaceuticals, Inc.b8defac4-9deb-433b-928e-0ef4ee0123a22025-10-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
levofloxacinLEVOFLOXACINBryant Ranch Prepackcbd5153f-fada-4682-b858-dc3b6e3173cc2025-09-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINLannett Company, Inc.362fb864-3afb-4841-a7c4-b64b1346aba02025-09-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINA-S Medication Solutions1538ec66-f385-401e-8cfb-d794691e71762025-07-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINProficient Rx LP64141d0d-0347-470f-a427-9925a2eb357e2025-07-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINRedpharm Drug0a0fd993-7bea-42d8-e063-6394a90a4e0e2025-04-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
LEVOFLOXACINLEVOFLOXACINAdvagen Pharma Limitedf2eb9444-333d-4b05-8cf3-2e6690a2bf992025-03-10Warnings, 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