FDA.reportPublic FDA data

Application 020695

Type
NDA
Sponsor
OTSUKA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RAXARGREPAFLOXACIN HYDROCHLORIDETABLET;ORALEQ 200MG BASENoNo
002RAXARGREPAFLOXACIN HYDROCHLORIDETABLET;ORALEQ 400MG BASENoNo
003RAXARGREPAFLOXACIN HYDROCHLORIDETABLET;ORALEQ 600MG BASENoNo

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
N020695-001RAXARGREPAFLOXACIN HYDROCHLORIDEEQ 200MG BASETABLET / ORAL1997-11-06
N020695-002RAXARGREPAFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORAL1998-05-14
N020695-003RAXARGREPAFLOXACIN HYDROCHLORIDEEQ 600MG BASETABLET / ORAL1998-05-14

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 22:38:342026-08N020695-001RAXAREQ 200MG BASETABLET / ORAL1997-11-0684e616aacf4f…
2026-09-14 22:38:342026-08N020695-002RAXAREQ 400MG BASETABLET / ORAL1998-05-1484e616aacf4f…
2026-09-14 22:38:342026-08N020695-003RAXAREQ 600MG BASETABLET / ORAL1998-05-1484e616aacf4f…
2026-08-18 06:07:402026-07N020695-001RAXAREQ 200MG BASETABLET / ORAL1997-11-06caaa826d4ba7…
2026-08-18 06:07:402026-07N020695-002RAXAREQ 400MG BASETABLET / ORAL1998-05-14caaa826d4ba7…
2026-08-18 06:07:402026-07N020695-003RAXAREQ 600MG BASETABLET / ORAL1998-05-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020695-001RAXAREQ 200MG BASETABLET / ORAL1997-11-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020695-002RAXAREQ 400MG BASETABLET / ORAL1998-05-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020695-003RAXAREQ 600MG BASETABLET / ORAL1998-05-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020695-001RAXAREQ 200MG BASETABLET / ORAL1997-11-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020695-002RAXAREQ 400MG BASETABLET / ORAL1998-05-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020695-003RAXAREQ 600MG BASETABLET / ORAL1998-05-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08N020695-001RAXAREQ 200MG BASETABLET / ORAL1997-11-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020695-002RAXAREQ 400MG BASETABLET / ORAL1998-05-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020695-003RAXAREQ 600MG BASETABLET / ORAL1998-05-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020695-001RAXAREQ 200MG BASETABLET / ORAL1997-11-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020695-002RAXAREQ 400MG BASETABLET / ORAL1998-05-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020695-003RAXAREQ 600MG BASETABLET / ORAL1998-05-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020695-001RAXAREQ 200MG BASETABLET / ORAL1997-11-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020695-002RAXAREQ 400MG BASETABLET / ORAL1998-05-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020695-003RAXAREQ 600MG BASETABLET / ORAL1998-05-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020695-001RAXAREQ 200MG BASETABLET / ORAL1997-11-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020695-002RAXAREQ 400MG BASETABLET / ORAL1998-05-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020695-003RAXAREQ 600MG BASETABLET / ORAL1998-05-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020695-001RAXAREQ 200MG BASETABLET / ORAL1997-11-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020695-002RAXAREQ 400MG BASETABLET / ORAL1998-05-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020695-003RAXAREQ 600MG BASETABLET / ORAL1998-05-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020695-001RAXAREQ 200MG BASETABLET / ORAL1997-11-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020695-002RAXAREQ 400MG BASETABLET / ORAL1998-05-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020695-003RAXAREQ 600MG BASETABLET / ORAL1998-05-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020695-001RAXAREQ 200MG BASETABLET / ORAL1997-11-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020695-002RAXAREQ 400MG BASETABLET / ORAL1998-05-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020695-003RAXAREQ 600MG BASETABLET / ORAL1998-05-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020695-001RAXAREQ 200MG BASETABLET / ORAL1997-11-06d06236e962d9…
2024-10-29 15:01 UTC2024-10N020695-002RAXAREQ 400MG BASETABLET / ORAL1998-05-14d06236e962d9…
2024-10-29 15:01 UTC2024-10N020695-003RAXAREQ 600MG BASETABLET / ORAL1998-05-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020695-001RAXAREQ 200MG BASETABLET / ORAL1997-11-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020695-002RAXAREQ 400MG BASETABLET / ORAL1998-05-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020695-003RAXAREQ 600MG BASETABLET / ORAL1998-05-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020695-001RAXAREQ 200MG BASETABLET / ORAL1997-11-06301d65b070ca…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
41560ORIG2004-07-15
41561SUPPL2004-06-28