Application 207619

Type: ANDA
Sponsor: BRECKENRIDGE PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CABAZITAXEL	CABAZITAXEL	SOLUTION;INTRAVENOUS	60MG/1.5ML (40MG/ML)	No	No

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A207619-001	CABAZITAXEL	CABAZITAXEL	60MG/1.5ML (40MG/ML)	SOLUTION / INTRAVENOUS			2022-06-23

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207619-001	CABAZITAXEL	60MG/1.5ML (40MG/ML)	SOLUTION / INTRAVENOUS		2022-06-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207619-001	CABAZITAXEL	60MG/1.5ML (40MG/ML)	SOLUTION / INTRAVENOUS		2022-06-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207619-001	CABAZITAXEL	60MG/1.5ML (40MG/ML)	SOLUTION / INTRAVENOUS		2022-06-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207619-001	CABAZITAXEL	60MG/1.5ML (40MG/ML)	SOLUTION / INTRAVENOUS		2022-06-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207619-001	CABAZITAXEL	60MG/1.5ML (40MG/ML)	SOLUTION / INTRAVENOUS		2022-06-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207619-001	CABAZITAXEL	60MG/1.5ML (40MG/ML)	SOLUTION / INTRAVENOUS		2022-06-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207619-001	CABAZITAXEL	60MG/1.5ML (40MG/ML)	SOLUTION / INTRAVENOUS		2022-06-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207619-001	CABAZITAXEL	60MG/1.5ML (40MG/ML)	SOLUTION / INTRAVENOUS		2022-06-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207619-001	CABAZITAXEL	60MG/1.5ML (40MG/ML)	SOLUTION / INTRAVENOUS		2022-06-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207619-001	CABAZITAXEL	60MG/1.5ML (40MG/ML)	SOLUTION / INTRAVENOUS		2022-06-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207619-001	CABAZITAXEL	60MG/1.5ML (40MG/ML)	SOLUTION / INTRAVENOUS		2022-06-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207619-001	CABAZITAXEL	60MG/1.5ML (40MG/ML)	SOLUTION / INTRAVENOUS		2022-06-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207619-001	CABAZITAXEL	60MG/1.5ML (40MG/ML)	SOLUTION / INTRAVENOUS		2022-06-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207619-001	CABAZITAXEL	60MG/1.5ML (40MG/ML)	SOLUTION / INTRAVENOUS		2022-06-23	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207619-001	CABAZITAXEL	60MG/1.5ML (40MG/ML)	SOLUTION / INTRAVENOUS		2022-06-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207619-001	CABAZITAXEL	60MG/1.5ML (40MG/ML)	SOLUTION / INTRAVENOUS		2022-06-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207619-001	CABAZITAXEL	60MG/1.5ML (40MG/ML)	SOLUTION / INTRAVENOUS		2022-06-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207619-001	CABAZITAXEL	60MG/1.5ML (40MG/ML)	SOLUTION / INTRAVENOUS		2022-06-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207619-001	CABAZITAXEL	60MG/1.5ML (40MG/ML)	SOLUTION / INTRAVENOUS		2022-06-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207619-001	CABAZITAXEL	60MG/1.5ML (40MG/ML)	SOLUTION / INTRAVENOUS		2022-06-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207619-001	CABAZITAXEL	60MG/1.5ML (40MG/ML)	SOLUTION / INTRAVENOUS		2022-06-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207619-001	CABAZITAXEL	60MG/1.5ML (40MG/ML)	SOLUTION / INTRAVENOUS		2022-06-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207619-001	CABAZITAXEL	60MG/1.5ML (40MG/ML)	SOLUTION / INTRAVENOUS		2022-06-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207619-001	CABAZITAXEL	60MG/1.5ML (40MG/ML)	SOLUTION / INTRAVENOUS		2022-06-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207619-001	CABAZITAXEL	60MG/1.5ML (40MG/ML)	SOLUTION / INTRAVENOUS		2022-06-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207619-001	CABAZITAXEL	60MG/1.5ML (40MG/ML)	SOLUTION / INTRAVENOUS		2022-06-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207619-001	CABAZITAXEL	60MG/1.5ML (40MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-06-23	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A207619-001	CABAZITAXEL	60MG/1.5ML (40MG/ML)	SOLUTION / INTRAVENOUS		2022-06-23	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207619-001	AP	1	`cb3db0bc1861…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Jevtana	CABAZITAXEL	Sanofi-Aventis U.S. LLC	de3d9c26-572b-4ea4-9b2d-dd58a2b3e8fa	2025-10-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CABAZITAXEL

Documents#

Document, Submission type, Date table
Document	Submission type	Date
55238	ORIG	2018-08-20