Application 022249

Type: NDA
Sponsor: CEPHALON

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TREANDA	BENDAMUSTINE HYDROCHLORIDE	POWDER;IV (INFUSION)	100MG/VIAL	Yes	Yes
002	TREANDA	BENDAMUSTINE HYDROCHLORIDE	POWDER;IV (INFUSION)	25MG/VIAL	Yes	Yes
003	TREANDA	BENDAMUSTINE HYDROCHLORIDE	SOLUTION;IV (INFUSION)	45MG/0.5ML (90MG/ML)	Yes	No
004	TREANDA	BENDAMUSTINE HYDROCHLORIDE	SOLUTION;IV (INFUSION)	180MG/2ML (90MG/ML)	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022249-001	TREANDA	BENDAMUSTINE HYDROCHLORIDE	100MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2008-03-20
N022249-002	TREANDA	BENDAMUSTINE HYDROCHLORIDE	25MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2009-05-01
N022249-003	TREANDA	BENDAMUSTINE HYDROCHLORIDE	45MG/0.5ML (90MG/ML)	SOLUTION / INTRAVENOUS		RLD	2013-09-13
N022249-004	TREANDA	BENDAMUSTINE HYDROCHLORIDE	180MG/2ML (90MG/ML)	SOLUTION / INTRAVENOUS		RLD	2013-09-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N022249-001	AP
N022249-002	AP

Orange Book patents#

Current patent rows page 1 of 1 · 46 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022249-001	8609863	2026-01-12		Drug product	2014-01-16
N022249-001	8791270	2026-01-12	U-1542	Drug product	2014-07-29
N022249-001	8895756	2026-01-12		Drug product	2014-11-26
N022249-001	8609863*PED	2026-07-12		Pediatric extension
N022249-001	8791270*PED	2026-07-12		Pediatric extension
N022249-001	8895756*PED	2026-07-12		Pediatric extension
N022249-001	8445524	2029-03-26	U-1402	Drug substance, Drug product	2013-06-04
N022249-001	8669279	2029-03-26	U-1402	Drug product	2014-10-30
N022249-001	8883836	2029-03-26	U-1402	Drug product	2014-11-13
N022249-001	9533955	2029-03-26	U-1949	Drug product
N022249-001	9533955	2029-03-26	U-1952	Drug product
N022249-001	8445524*PED	2029-09-26		Pediatric extension
N022249-001	8669279*PED	2029-09-26		Pediatric extension
N022249-001	8883836*PED	2029-09-26		Pediatric extension
N022249-001	9533955*PED	2029-09-26		Pediatric extension
N022249-001	8436190	2030-10-26		Drug product	2013-06-04
N022249-001	8436190*PED	2031-04-26		Pediatric extension
N022249-002	8609863	2026-01-12		Drug product	2014-01-16
N022249-002	8791270	2026-01-12	U-1542	Drug product	2014-07-29
N022249-002	8895756	2026-01-12		Drug product	2014-11-26
N022249-002	8609863*PED	2026-07-12		Pediatric extension
N022249-002	8791270*PED	2026-07-12		Pediatric extension
N022249-002	8895756*PED	2026-07-12		Pediatric extension
N022249-002	8445524	2029-03-26	U-1402	Drug substance, Drug product	2013-06-04
N022249-002	8669279	2029-03-26	U-1402	Drug product	2014-10-30
N022249-002	8883836	2029-03-26	U-1402	Drug product	2014-11-13
N022249-002	9533955	2029-03-26	U-1949	Drug product	2017-01-13
N022249-002	9533955	2029-03-26	U-1952	Drug product	2017-01-13
N022249-002	8445524*PED	2029-09-26		Pediatric extension
N022249-002	8669279*PED	2029-09-26		Pediatric extension
N022249-002	8883836*PED	2029-09-26		Pediatric extension
N022249-002	9533955*PED	2029-09-26		Pediatric extension
N022249-002	8436190	2030-10-26		Drug product	2013-06-04
N022249-002	8436190*PED	2031-04-26		Pediatric extension
N022249-003	8791270	2026-01-12	U-1542	Drug product	2014-12-09
N022249-003	8791270*PED	2026-07-12		Pediatric extension
N022249-003	8445524	2029-03-26		Drug substance	2013-09-17
N022249-003	8344006	2029-09-23	U-1402	Drug product
N022249-003	8445524*PED	2029-09-26		Pediatric extension
N022249-003	8344006*PED	2030-03-23		Pediatric extension
N022249-004	8791270	2026-01-12	U-1542	Drug product	2014-12-09
N022249-004	8791270*PED	2026-07-12		Pediatric extension
N022249-004	8445524	2029-03-26		Drug substance	2013-09-17
N022249-004	8344006	2029-09-23	U-1402	Drug product
N022249-004	8445524*PED	2029-09-26		Pediatric extension
N022249-004	8344006*PED	2030-03-23		Pediatric extension

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 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N022249-001	TREANDA	100MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2008-03-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022249-002	TREANDA	25MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2009-05-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022249-003	TREANDA	45MG/0.5ML (90MG/ML)	SOLUTION / INTRAVENOUS		RLD	2013-09-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022249-004	TREANDA	180MG/2ML (90MG/ML)	SOLUTION / INTRAVENOUS		RLD	2013-09-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022249-001	TREANDA	100MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2008-03-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022249-002	TREANDA	25MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2009-05-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022249-003	TREANDA	45MG/0.5ML (90MG/ML)	SOLUTION / INTRAVENOUS		RLD	2013-09-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022249-004	TREANDA	180MG/2ML (90MG/ML)	SOLUTION / INTRAVENOUS		RLD	2013-09-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022249-001	TREANDA	100MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2008-03-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022249-002	TREANDA	25MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2009-05-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022249-003	TREANDA	45MG/0.5ML (90MG/ML)	SOLUTION / INTRAVENOUS		RLD	2013-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022249-004	TREANDA	180MG/2ML (90MG/ML)	SOLUTION / INTRAVENOUS		RLD	2013-09-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022249-001	TREANDA	100MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2008-03-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022249-002	TREANDA	25MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2009-05-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022249-003	TREANDA	45MG/0.5ML (90MG/ML)	SOLUTION / INTRAVENOUS		RLD	2013-09-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022249-004	TREANDA	180MG/2ML (90MG/ML)	SOLUTION / INTRAVENOUS		RLD	2013-09-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022249-001	TREANDA	100MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2008-03-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022249-002	TREANDA	25MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2009-05-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022249-003	TREANDA	45MG/0.5ML (90MG/ML)	SOLUTION / INTRAVENOUS		RLD	2013-09-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022249-004	TREANDA	180MG/2ML (90MG/ML)	SOLUTION / INTRAVENOUS		RLD	2013-09-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022249-001	TREANDA	100MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2008-03-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022249-002	TREANDA	25MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2009-05-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022249-003	TREANDA	45MG/0.5ML (90MG/ML)	SOLUTION / INTRAVENOUS		RLD	2013-09-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022249-004	TREANDA	180MG/2ML (90MG/ML)	SOLUTION / INTRAVENOUS		RLD	2013-09-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022249-001	TREANDA	100MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2008-03-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022249-002	TREANDA	25MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2009-05-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022249-003	TREANDA	45MG/0.5ML (90MG/ML)	SOLUTION / INTRAVENOUS		RLD	2013-09-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022249-004	TREANDA	180MG/2ML (90MG/ML)	SOLUTION / INTRAVENOUS		RLD	2013-09-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022249-001	TREANDA	100MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2008-03-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022249-002	TREANDA	25MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2009-05-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022249-003	TREANDA	45MG/0.5ML (90MG/ML)	SOLUTION / INTRAVENOUS		RLD	2013-09-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022249-004	TREANDA	180MG/2ML (90MG/ML)	SOLUTION / INTRAVENOUS		RLD	2013-09-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022249-001	TREANDA	100MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2008-03-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022249-002	TREANDA	25MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2009-05-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022249-003	TREANDA	45MG/0.5ML (90MG/ML)	SOLUTION / INTRAVENOUS		RLD	2013-09-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022249-004	TREANDA	180MG/2ML (90MG/ML)	SOLUTION / INTRAVENOUS		RLD	2013-09-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022249-001	TREANDA	100MG/VIAL	POWDER / IV (INFUSION)	AP	RLD, RS	2008-03-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022249-002	TREANDA	25MG/VIAL	POWDER / IV (INFUSION)	AP	RLD, RS	2009-05-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022249-003	TREANDA	45MG/0.5ML (90MG/ML)	SOLUTION / IV (INFUSION)		RLD	2013-09-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022249-004	TREANDA	180MG/2ML (90MG/ML)	SOLUTION / IV (INFUSION)		RLD	2013-09-13	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 52 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N022249-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022249-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022249-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022249-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022249-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022249-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022249-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022249-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022249-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022249-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022249-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022249-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022249-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022249-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022249-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022249-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022249-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022249-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022249-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022249-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022249-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022249-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022249-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022249-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022249-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022249-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022249-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022249-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022249-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022249-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022249-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022249-002	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022249-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022249-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022249-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N022249-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022249-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N022249-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022249-001	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022249-002	AP	1	`a72a2bbeb626…`

Observed Orange Book patent history#

Patent history page 1 of 49 · 1,942 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N022249-001	8609863	2026-01-12		Drug product	2014-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022249-001	8791270	2026-01-12	U-1542	Drug product	2014-07-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022249-001	8895756	2026-01-12		Drug product	2014-11-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022249-001	8609863*PED	2026-07-12		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022249-001	8791270*PED	2026-07-12		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022249-001	8895756*PED	2026-07-12		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022249-001	8445524	2029-03-26	U-1402	Drug substance, Drug product	2013-06-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022249-001	8669279	2029-03-26	U-1402	Drug product	2014-10-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022249-001	8883836	2029-03-26	U-1402	Drug product	2014-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022249-001	9533955	2029-03-26	U-1952	Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022249-001	9533955	2029-03-26	U-1949	Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022249-001	8445524*PED	2029-09-26		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022249-001	8669279*PED	2029-09-26		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022249-001	8883836*PED	2029-09-26		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022249-001	9533955*PED	2029-09-26		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022249-001	8436190	2030-10-26		Drug product	2013-06-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022249-001	8436190*PED	2031-04-26		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022249-002	8609863	2026-01-12		Drug product	2014-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022249-002	8791270	2026-01-12	U-1542	Drug product	2014-07-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022249-002	8895756	2026-01-12		Drug product	2014-11-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022249-002	8609863*PED	2026-07-12		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022249-002	8791270*PED	2026-07-12		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022249-002	8895756*PED	2026-07-12		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022249-002	8445524	2029-03-26	U-1402	Drug substance, Drug product	2013-06-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022249-002	8669279	2029-03-26	U-1402	Drug product	2014-10-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022249-002	8883836	2029-03-26	U-1402	Drug product	2014-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022249-002	9533955	2029-03-26	U-1952	Drug product	2017-01-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022249-002	9533955	2029-03-26	U-1949	Drug product	2017-01-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022249-002	8445524*PED	2029-09-26		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022249-002	8669279*PED	2029-09-26		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022249-002	8883836*PED	2029-09-26		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022249-002	9533955*PED	2029-09-26		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022249-002	8436190	2030-10-26		Drug product	2013-06-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022249-002	8436190*PED	2031-04-26		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022249-003	8791270	2026-01-12	U-1542	Drug product	2014-12-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022249-003	8791270*PED	2026-07-12		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022249-003	8445524	2029-03-26		Drug substance	2013-09-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022249-003	8344006	2029-09-23	U-1402	Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022249-003	8445524*PED	2029-09-26		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022249-003	8344006*PED	2030-03-23		Pediatric extension		`84e616aacf4f…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2023-01-26 05:58 UTC	2023-01	N022249-001	ODE*	2022-12-07	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N022249-002	ODE*	2022-12-07	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N022249-003	ODE*	2022-12-07	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N022249-004	ODE*	2022-12-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022249-001	ODE*	2022-12-07	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022249-002	ODE*	2022-12-07	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022249-003	ODE*	2022-12-07	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022249-004	ODE*	2022-12-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022249-001	ODE*	2022-12-07	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N022249-002	ODE*	2022-12-07	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N022249-003	ODE*	2022-12-07	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N022249-004	ODE*	2022-12-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022249-001	ODE*	2022-12-07	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N022249-002	ODE*	2022-12-07	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N022249-003	ODE*	2022-12-07	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N022249-004	ODE*	2022-12-07	`e64feba35796…`

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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bendamustine Hydrochloride	BENDAMUSTINE HYDROCHLORIDE	Apotex Corp	085dd54c-4212-d879-afef-ee52732a48c0	2026-09-09	Warnings, Adverse reactions	Name fallback generic name: BENDAMUSTINE HYDROCHLORIDE
BENDAMUSTINE HYDROCHLORIDE	BENDAMUSTINE HYDROCHLORIDE	Avyxa Pharma, LLC	f359e7c6-d104-457d-a7fe-597c74440353	2026-05-14	Warnings, Adverse reactions	Name fallback generic name: BENDAMUSTINE HYDROCHLORIDE
VIVIMUSTA	BENDAMUSTINE HYDROCHLORIDE	Azurity Pharmaceuticals, Inc.	4df6548f-c4ad-4eb2-a54f-19766a3d90ca	2025-04-03	Warnings, Adverse reactions	Name fallback generic name: BENDAMUSTINE HYDROCHLORIDE
BENDAMUSTINE HYDROCHLORIDE	BENDAMUSTINE HYDROCHLORIDE	Baxter Healthcare Corporation	766b73e2-49bb-47f9-bbb1-44cfa1a3197e	2025-02-10	Warnings, Adverse reactions	Name fallback generic name: BENDAMUSTINE HYDROCHLORIDE
BELRAPZO	BENDAMUSTINE HYDROCHLORIDE	Eagle Pharmaceuticals, Inc	9759a4ae-82ca-40cf-9c02-e1cadb21cbdc	2024-09-23	Warnings, Adverse reactions	Name fallback generic name: BENDAMUSTINE HYDROCHLORIDE
bendamustine hydrochloride	BENDAMUSTINE HYDROCHLORIDE	Accord Healthcare, Inc.	33867f0f-f317-1fd0-e054-00144ff8d46c	2024-07-18	Warnings, Adverse reactions	Name fallback generic name: BENDAMUSTINE HYDROCHLORIDE
bendamustine hydrochloride	BENDAMUSTINE HYDROCHLORIDE	BluePoint Laboratories	0df025d2-c093-427a-b599-f605e71fe835	2024-03-29	Warnings, Adverse reactions	Name fallback generic name: BENDAMUSTINE HYDROCHLORIDE
VIVIMUSTA	BENDAMUSTINE HYDROCHLORIDE	Slayback Pharma LLC	cbcc6eb7-aa62-4599-af49-05203fedb4bb	2024-02-27	Warnings, Adverse reactions	Name fallback generic name: BENDAMUSTINE HYDROCHLORIDE
Bendeka	BENDAMUSTINE HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	ace9a43b-f9bd-4896-abfe-0ef4fec67ddf	2024-01-19	Warnings, Adverse reactions	Name fallback generic name: BENDAMUSTINE HYDROCHLORIDE
BENDAMUSTINE HYDROCHLORIDE	BENDAMUSTINE HYDROCHLORIDE	Eugia US LLC	dbe34bc1-06b2-493f-8859-e8b143357aa8	2023-07-05	Warnings, Adverse reactions	Name fallback generic name: BENDAMUSTINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63459-390	TREANDA	Bendamustine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-390	TREANDA	Bendamustine Hydrochloride	Cephalon, LLC	NDA	Current
63459-390	TREANDA	Bendamustine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-390	TREANDA	Bendamustine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-390	TREANDA	Bendamustine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-390	TREANDA	Bendamustine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-391	TREANDA	Bendamustine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-391	TREANDA	Bendamustine Hydrochloride	Cephalon, LLC	NDA	Current
63459-391	TREANDA	Bendamustine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-391	TREANDA	Bendamustine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-391	TREANDA	Bendamustine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-391	TREANDA	Bendamustine Hydrochloride	Cephalon, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
72557	SUPPL	2022-11-03
72480	SUPPL	2022-10-27
67772	SUPPL	2021-06-14
67765	SUPPL	2021-06-11
62854	SUPPL	2020-05-08
61031	SUPPL	2019-11-22
61013	SUPPL	2019-11-22
50836	SUPPL	2017-12-22
50782	SUPPL	2017-12-20
45566	SUPPL	2016-10-20
45906	SUPPL	2016-10-19
42464	SUPPL	2016-07-27
42463	SUPPL	2016-07-27
38422	SUPPL	2015-11-12
29442	SUPPL	2015-11-09
7088	SUPPL	2015-09-04
38423	SUPPL	2015-09-02
7087	SUPPL	2015-03-11
38421	SUPPL	2015-03-10
42462	SUPPL	2014-08-01
17120	SUPPL	2013-09-17
29441	SUPPL	2013-08-29
17119	SUPPL	2013-08-29
17118	SUPPL	2012-06-27
7086	SUPPL	2012-06-27
51261	SUPPL	2011-07-07
7085	SUPPL	2010-12-28
38420	SUPPL	2010-12-26
29440	SUPPL	2010-03-04
17117	SUPPL	2010-03-03
51260	SUPPL	2010-01-23
51259	SUPPL	2010-01-19
38418	SUPPL	2009-05-11
29439	SUPPL	2009-05-06
38419	SUPPL	2009-04-28
7084	SUPPL	2009-04-27
44714	ORIG	2008-05-08
21969	ORIG	2008-05-08
29438	ORIG	2008-03-21
38417	ORIG	2008-03-20
53186	SUPPL	1900-01-01
53185	SUPPL	1900-01-01