FDA.reportPublic FDA data

Application 207970

Type
NDA
Sponsor
ACTAVIS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CABAZITAXEL INJECTIONCABAZITAXELINJECTABLE;INJECTION40MG/4MLNoNo
002CABAZITAXEL INJECTIONCABAZITAXELINJECTABLE;INJECTION60MG/6MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N207970-001CABAZITAXELCABAZITAXEL60MG/6ML (10MG/ML)SOLUTION / INTRAVENOUSRLD2024-03-14

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N207970-001CABAZITAXEL60MG/6ML (10MG/ML)SOLUTION / INTRAVENOUSRLD2024-03-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207970-001CABAZITAXEL60MG/6ML (10MG/ML)SOLUTION / INTRAVENOUSRLD2024-03-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08N207970-001CABAZITAXEL60MG/6ML (10MG/ML)SOLUTION / INTRAVENOUSRLD2024-03-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N207970-001CABAZITAXEL60MG/6ML (10MG/ML)SOLUTION / INTRAVENOUSRLD2024-03-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N207970-001CABAZITAXEL60MG/6ML (10MG/ML)SOLUTION / INTRAVENOUSRLD2024-03-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N207970-001CABAZITAXEL60MG/6ML (10MG/ML)SOLUTION / INTRAVENOUSRLD2024-03-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N207970-001CABAZITAXEL60MG/6ML (10MG/ML)SOLUTION / INTRAVENOUSRLD2024-03-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N207970-001CABAZITAXEL60MG/6ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2024-03-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N207970-001CABAZITAXEL60MG/6ML (10MG/ML)SOLUTION / INTRAVENOUSRLD2024-03-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N207970-001CABAZITAXEL60MG/6ML (10MG/ML)SOLUTION / INTRAVENOUSRLD2024-03-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N207970-001CABAZITAXEL60MG/6ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2024-03-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N207970-001CABAZITAXEL60MG/6ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2024-03-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N207970-001CABAZITAXEL60MG/6ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2024-03-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05N207970-001CABAZITAXEL60MG/6ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2024-03-148072bd15b7f6…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N207970-001CABAZITAXEL60MG/6ML (10MG/ML)SOLUTION / INTRAVENOUSRLD2024-03-14a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JevtanaCABAZITAXELSanofi-Aventis U.S. LLCde3d9c26-572b-4ea4-9b2d-dd58a2b3e8fa2025-10-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CABAZITAXEL

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81500ORIG 2025-03-10
78391ORIG 2024-03-14
78390ORIG 2024-03-14
32872ORIG2015-08-21