FDA.reportPublic FDA data

Application 021277

Type
NDA
Sponsor
BAYER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINERMOXIFLOXACIN HYDROCHLORIDESOLUTION;INTRAVENOUS400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N021277-001AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINERMOXIFLOXACIN HYDROCHLORIDE400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2001-11-30

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 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N021277-001AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2001-11-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021277-001AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2001-11-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021277-001AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2001-11-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08N021277-001AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2001-11-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021277-001AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2001-11-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021277-001AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2001-11-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021277-001AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2001-11-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021277-001AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2001-11-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021277-001AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2001-11-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021277-001AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2001-11-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021277-001AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2001-11-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021277-001AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2001-11-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021277-001AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2001-11-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021277-001AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2001-11-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021277-001AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2001-11-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021277-001AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2001-11-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021277-001AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER400MG/250ML (1.6MG/ML)SOLUTION / INTRAVENOUSRLD2001-11-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021277-001AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER400MG/250ML (1.6MG/ML)SOLUTION / INTRAVENOUSRLD2001-11-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021277-001AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**SOLUTION / INTRAVENOUSRLD2001-11-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021277-001AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2001-11-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021277-001AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**SOLUTION / INTRAVENOUSRLD2001-11-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021277-001AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**SOLUTION / INTRAVENOUSRLD2001-11-3087673890dc5c…
2021-03-12 10:30 UTC2021-03N021277-001AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**SOLUTION / INTRAVENOUSRLD2001-11-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021277-001AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**SOLUTION / INTRAVENOUSRLD2001-11-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021277-001AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**SOLUTION / INTRAVENOUSRLD2001-11-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021277-001AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**SOLUTION / INTRAVENOUSRLD2001-11-303f01610625f2…
2019-09-15 20:21 UTC2019-09N021277-001AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**SOLUTION / INTRAVENOUSRLD2001-11-30b00525d2431f…
2019-07-19 19:46 UTC2019-07N021277-001AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**SOLUTION / INTRAVENOUSRLD2001-11-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021277-001AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2001-11-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021277-001AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2001-11-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021277-001AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2001-11-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021277-001AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2001-11-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021277-001AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2001-11-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021277-001AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2001-11-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021277-001AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2001-11-303f0d92c62455…
2023-05-13 08:27 UTC2023-05N021277-001AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2001-11-30053a50430f4f…
2023-01-26 05:58 UTC2023-01N021277-001AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2001-11-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021277-001AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2001-11-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021277-001AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2001-11-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021277-001AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2001-11-30e64feba35796…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021277-00165480792020-07-25U-298Drug product74a2ff9319b5…
2020-12-22 03:56 UTC2020-12N021277-00165480792020-07-25U-298Drug product8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021277-00165480792020-07-25U-298Drug productc0c555d07b60…
2019-12-14 00:12 UTC2019-12N021277-00165480792020-07-25U-298Drug product3f01610625f2…
2019-09-15 20:21 UTC2019-09N021277-00165480792020-07-25U-298Drug productb00525d2431f…
2019-07-19 19:46 UTC2019-07N021277-00165480792020-07-25U-298Drug productea99ee380514…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12N021277-001M-1852019-09-2774a2ff9319b5…
2019-12-14 00:12 UTC2019-12N021277-001M-1852019-09-273f01610625f2…
2019-09-15 20:21 UTC2019-09N021277-001M-1852019-09-27b00525d2431f…
2019-07-19 19:46 UTC2019-07N021277-001M-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 2 of 2 · 25 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MoxifloxacinMOXIFLOXACIN HYDROCHLORIDEHp Halden Pharma AS6067b2ee-2171-49bb-aa07-1d401ebf4f2e2024-07-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MOXIFLOXACIN HYDROCHLORIDE
MoxifloxacinMOXIFLOXACIN HYDROCHLORIDEFresenius Kabi USA, LLCa4e28b09-714b-46e7-b4e6-0163cad78fc52024-05-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MOXIFLOXACIN HYDROCHLORIDE
Moxifloxacin HydrochlorideMOXIFLOXACIN HYDROCHLORIDEA-S Medication Solutionsc71e5987-edd7-4c38-b646-3e48a6e51bf42023-11-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MOXIFLOXACIN HYDROCHLORIDE
Moxifloxacin HydrochlorideMOXIFLOXACIN HYDROCHLORIDEUpsher-Smith Laboratories, LLC5a5d72e2-aa39-4ead-af72-d3cabe72a5b72023-05-30Warnings, Adverse reactionsName fallback
generic name: MOXIFLOXACIN HYDROCHLORIDE
Moxifloxacin Ophthalmic SolutionMOXIFLOXACIN HYDROCHLORIDESandoz Incfc88791b-24da-48a4-85f5-93a8af3d0b512020-06-15Warnings, Adverse reactionsName fallback
generic name: MOXIFLOXACIN HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0085-1737Aveloxmoxifloxacin hydrochlorideSchering Plough CorporationNDACurrent
50419-537Aveloxmoxifloxacin hydrochlorideBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-537Aveloxmoxifloxacin hydrochlorideBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-537Aveloxmoxifloxacin hydrochlorideBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-537Aveloxmoxifloxacin hydrochlorideBayer HealthCare Pharmaceuticals Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82860SUPPL 2025-07-14
82859SUPPL 2025-07-14
82827SUPPL 2025-07-14
62850SUPPL2020-05-07
62849SUPPL2020-05-07
62843SUPPL2020-05-07
58621SUPPL2019-05-08
58620SUPPL2019-05-08
58573SUPPL2019-05-06
56067SUPPL2018-10-23
56034SUPPL2018-10-19
47513SUPPL2017-03-09
45488SUPPL2016-09-30
45435SUPPL2016-09-30
45434SUPPL2016-09-30
27340SUPPL2016-07-26
14850SUPPL2016-07-26
14849SUPPL2015-06-05
27339SUPPL2015-05-13
14848SUPPL2014-12-03
27338SUPPL2014-11-24
27337SUPPL2013-08-16
36550SUPPL2013-08-15
27336SUPPL2012-12-26
36549SUPPL2012-12-21
14847SUPPL2012-09-11
27335SUPPL2012-08-28
36548SUPPL2011-10-20
27334SUPPL2011-10-20
14846SUPPL2011-10-20
4873SUPPL2011-10-20
27333SUPPL2011-08-08
14845SUPPL2011-03-04
27332SUPPL2011-03-02
4872SUPPL2010-11-02
36547SUPPL2010-10-25
27331SUPPL2010-04-09
14844SUPPL2010-03-05
27330SUPPL2010-01-25
14843SUPPL2009-12-02
4871SUPPL2009-06-29
14842SUPPL2009-05-15
27329SUPPL2009-05-05
14841SUPPL2009-01-02
4869SUPPL2008-12-31
36546SUPPL2008-10-09
4870SUPPL2008-10-07
36545SUPPL2008-02-25
27328SUPPL2008-02-20
42071SUPPL2008-02-19
21568SUPPL2008-02-19
36544SUPPL2007-06-04
27327SUPPL2007-06-04
36543SUPPL2005-11-30
27326SUPPL2005-11-30
14840SUPPL2005-11-30
4868SUPPL2005-11-30
27325SUPPL2005-06-14
14839SUPPL2005-06-14
36542SUPPL2004-07-30
4867SUPPL2004-07-30
21567ORIG2004-05-27
14837SUPPL2004-05-27
4865SUPPL2004-05-26
14838SUPPL2004-04-05
4866SUPPL2004-03-10
36541SUPPL2003-10-10
27324SUPPL2003-10-06
27323SUPPL2003-03-10
27322SUPPL2003-03-10
4864SUPPL2003-03-10
36540SUPPL2003-02-28
36539SUPPL2003-02-28
14836SUPPL2003-02-28
27321SUPPL2002-06-12
14835SUPPL2002-06-12
27320SUPPL2002-05-22
36538SUPPL2002-05-16
4863SUPPL2002-05-16
14834ORIG2001-11-30
4862ORIG2001-11-30