FDA.reportPublic FDA data

Application 205572

Type
NDA
Sponsor
FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MOXIFLOXACIN HYDROCHLORIDEMOXIFLOXACIN HYDROCHLORIDESOLUTION;INTRAVENOUSEQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)YesYes

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
N205572-001MOXIFLOXACIN HYDROCHLORIDEMOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2015-04-03

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 06:07:402026-07N205572-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2015-04-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N205572-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2015-04-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205572-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2015-04-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08N205572-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2015-04-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205572-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2015-04-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205572-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2015-04-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205572-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2015-04-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205572-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2015-04-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205572-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2015-04-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205572-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2015-04-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N205572-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2015-04-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N205572-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2015-04-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N205572-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2015-04-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N205572-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2015-04-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05N205572-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2015-04-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N205572-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2015-04-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N205572-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2015-04-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N205572-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2015-04-034b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N205572-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2015-04-0374a2ff9319b5…
2022-03-09 01:35 UTC2022-03N205572-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2015-04-03bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N205572-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2015-04-03782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N205572-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2015-04-0387673890dc5c…
2021-03-12 10:30 UTC2021-03N205572-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2015-04-035aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N205572-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2015-04-038869cabd3fbd…
2020-11-12 02:37 UTC2020-11N205572-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2015-04-03c0c555d07b60…
2019-12-14 00:12 UTC2019-12N205572-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2015-04-033f01610625f2…
2019-09-15 20:21 UTC2019-09N205572-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2015-04-03b00525d2431f…
2019-07-19 19:46 UTC2019-07N205572-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2015-04-03ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N205572-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2015-04-036a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N205572-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2015-04-031c564ffb4f44…
2023-12-20 04:57 UTC2023-12N205572-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2015-04-03ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N205572-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2015-04-03a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N205572-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2015-04-039b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N205572-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2015-04-03a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N205572-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2015-04-033f0d92c62455…
2023-05-13 08:27 UTC2023-05N205572-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2015-04-03053a50430f4f…
2023-01-26 05:58 UTC2023-01N205572-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2015-04-033bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N205572-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2015-04-033a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N205572-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2015-04-03f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N205572-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2015-04-03e64feba35796…

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 1 · 2 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 reactionsExact identifier
application applno (NDA): 205572
application number: NDA205572
ndc (product): 66298-8507
MoxifloxacinMOXIFLOXACIN HYDROCHLORIDEFresenius Kabi USA, LLCa4e28b09-714b-46e7-b4e6-0163cad78fc52024-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 205572
application number: NDA205572
ndc (product): 63323-850

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63323-850MoxifloxacinMOXIFLOXACIN HYDROCHLORIDEFresenius Kabi USA, LLCNDACurrent
63323-850MoxifloxacinMOXIFLOXACIN HYDROCHLORIDEFresenius Kabi USA, LLCNDACurrent
63323-850MoxifloxacinMOXIFLOXACIN HYDROCHLORIDEFresenius Kabi USA, LLCNDACurrent
66298-8507MoxifloxacinMOXIFLOXACIN HYDROCHLORIDEFresenius Kabi Norge ASNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
62380SUPPL2020-03-31
62379SUPPL2020-03-31
62360SUPPL2020-03-30
58634SUPPL2019-05-08
58633SUPPL2019-05-08
58593SUPPL2019-05-07
56073SUPPL2018-10-23
56032SUPPL2018-10-19
43982SUPPL2016-07-26
32688SUPPL2016-07-26
19659SUPPL2016-07-26
43493ORIG2016-03-02
24498ORIG2016-03-02
19658ORIG2015-04-10
10466ORIG2015-04-08