Application 211530

Type: NDA
Sponsor: HOSPIRA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BENDAMUSTINE	BENDAMUSTINE	SOLUTION;IV (INFUSION)	25MG/ML	No	No
002	BENDAMUSTINE	BENDAMUSTINE	SOLUTION;IV (INFUSION)	100MG/4ML	No	No
003	BENDAMUSTINE	BENDAMUSTINE	SOLUTION;IV (INFUSION)	200MG/8ML	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N211530-001	BENDAMUSTINE HYDROCHLORIDE	BENDAMUSTINE HYDROCHLORIDE	25MG/ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-12-15
N211530-002	BENDAMUSTINE HYDROCHLORIDE	BENDAMUSTINE HYDROCHLORIDE	100MG/4ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-12-15
N211530-003	BENDAMUSTINE HYDROCHLORIDE	BENDAMUSTINE HYDROCHLORIDE	200MG/8ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-12-15

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 · 75 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N211530-001	BENDAMUSTINE HYDROCHLORIDE	25MG/ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-12-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211530-002	BENDAMUSTINE HYDROCHLORIDE	100MG/4ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-12-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211530-003	BENDAMUSTINE HYDROCHLORIDE	200MG/8ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-12-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211530-001	BENDAMUSTINE HYDROCHLORIDE	25MG/ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211530-002	BENDAMUSTINE HYDROCHLORIDE	100MG/4ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211530-003	BENDAMUSTINE HYDROCHLORIDE	200MG/8ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-12-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211530-001	BENDAMUSTINE HYDROCHLORIDE	25MG/ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211530-002	BENDAMUSTINE HYDROCHLORIDE	100MG/4ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211530-003	BENDAMUSTINE HYDROCHLORIDE	200MG/8ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-12-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211530-001	BENDAMUSTINE HYDROCHLORIDE	25MG/ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-12-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211530-002	BENDAMUSTINE HYDROCHLORIDE	100MG/4ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-12-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211530-003	BENDAMUSTINE HYDROCHLORIDE	200MG/8ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-12-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211530-001	BENDAMUSTINE HYDROCHLORIDE	25MG/ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-12-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211530-002	BENDAMUSTINE HYDROCHLORIDE	100MG/4ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-12-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211530-003	BENDAMUSTINE HYDROCHLORIDE	200MG/8ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-12-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211530-001	BENDAMUSTINE HYDROCHLORIDE	25MG/ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-12-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211530-002	BENDAMUSTINE HYDROCHLORIDE	100MG/4ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-12-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211530-003	BENDAMUSTINE HYDROCHLORIDE	200MG/8ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-12-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211530-001	BENDAMUSTINE HYDROCHLORIDE	25MG/ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-12-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211530-002	BENDAMUSTINE HYDROCHLORIDE	100MG/4ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-12-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211530-003	BENDAMUSTINE HYDROCHLORIDE	200MG/8ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-12-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211530-001	BENDAMUSTINE HYDROCHLORIDE	25MG/ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-12-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211530-002	BENDAMUSTINE HYDROCHLORIDE	100MG/4ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-12-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211530-003	BENDAMUSTINE HYDROCHLORIDE	200MG/8ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-12-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211530-001	BENDAMUSTINE HYDROCHLORIDE	25MG/ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-12-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211530-002	BENDAMUSTINE HYDROCHLORIDE	100MG/4ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-12-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211530-003	BENDAMUSTINE HYDROCHLORIDE	200MG/8ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-12-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211530-001	BENDAMUSTINE HYDROCHLORIDE	25MG/ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-12-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211530-002	BENDAMUSTINE HYDROCHLORIDE	100MG/4ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-12-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211530-003	BENDAMUSTINE HYDROCHLORIDE	200MG/8ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-12-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211530-001	BENDAMUSTINE HYDROCHLORIDE	25MG/ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-12-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211530-002	BENDAMUSTINE HYDROCHLORIDE	100MG/4ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-12-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211530-003	BENDAMUSTINE HYDROCHLORIDE	200MG/8ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-12-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211530-001	BENDAMUSTINE HYDROCHLORIDE	25MG/ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-12-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211530-002	BENDAMUSTINE HYDROCHLORIDE	100MG/4ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-12-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211530-003	BENDAMUSTINE HYDROCHLORIDE	200MG/8ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-12-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211530-001	BENDAMUSTINE HYDROCHLORIDE	25MG/ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-12-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211530-002	BENDAMUSTINE HYDROCHLORIDE	100MG/4ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-12-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211530-003	BENDAMUSTINE HYDROCHLORIDE	200MG/8ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-12-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211530-001	BENDAMUSTINE HYDROCHLORIDE	25MG/ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-12-15	`1e350fbaab3a…`

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
Bendamustine	BENDAMUSTINE HCL	Meitheal Pharmaceuticals Inc.	40f6f58d-d9ac-4f65-9fc7-16984bf1f180	2026-05-11	Warnings, Adverse reactions	Name fallback brand name: Bendamustine

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77318	SUPPL	2024-01-26
77309	SUPPL	2024-01-26
75996	ORIG	2023-10-31
72912	ORIG	2022-12-16
57574	ORIG	2019-02-13