Application 205580

Type: NDA
Sponsor: EAGLE PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BELRAPZO	BENDAMUSTINE HYDROCHLORIDE	SOLUTION;IV (INFUSION)	100MG/4ML (25MG/ML)	Yes	Yes

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
N205580-001	BELRAPZO	BENDAMUSTINE HYDROCHLORIDE	100MG/4ML (25MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-05-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N205580-001	AP

Orange Book patents#

Current patent rows page 1 of 1 · 20 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N205580-001	8791270	2026-01-12	U-1971	Drug product	2018-08-01
N205580-001	8791270	2026-01-12	U-1972	Drug product	2018-08-01
N205580-001	10010533	2031-01-28		Drug product	2018-07-03
N205580-001	11103483	2031-01-28	U-1971	Drug product	2021-08-31
N205580-001	11103483	2031-01-28	U-1972	Drug product	2021-08-31
N205580-001	11844783	2031-01-28	U-1542		2023-12-19
N205580-001	11844783	2031-01-28	U-1971		2023-12-19
N205580-001	11844783	2031-01-28	U-1972		2023-12-19
N205580-001	11872214	2031-01-28		Drug product	2024-01-16
N205580-001	12138248	2031-01-28		Drug product	2025-01-27
N205580-001	12350257	2031-01-28	U-1542	Drug product	2025-07-14
N205580-001	12350257	2031-01-28	U-1971	Drug product	2025-07-14
N205580-001	12350257	2031-01-28	U-1972	Drug product	2025-07-14
N205580-001	9265831	2031-01-28		Drug product	2018-08-01
N205580-001	9572796	2031-01-28	U-1971	Drug product	2018-08-01
N205580-001	9572796	2031-01-28	U-1972	Drug product	2018-08-01
N205580-001	9572797	2031-01-28	U-1971		2018-08-01
N205580-001	9572797	2031-01-28	U-1972		2018-08-01
N205580-001	8609707	2031-08-11	U-1971	Drug product	2018-08-01
N205580-001	8609707	2031-08-11	U-1972	Drug product	2018-08-01

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 · 41 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
2026-02-19 14:30 UTC	2026-02	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-05-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-05-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-05-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-05-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-05-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-05-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-05-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-05-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-05-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-05-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-05-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-05-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-05-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-05-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / IV (INFUSION)		RLD, RS	2018-05-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / IV (INFUSION)		RLD, RS	2018-05-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / IV (INFUSION)		RLD, RS	2018-05-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / IV (INFUSION)		RLD, RS	2018-05-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / IV (INFUSION)		RLD, RS	2018-05-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / IV (INFUSION)		RLD, RS	2018-05-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / IV (INFUSION)		RLD, RS	2018-05-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / IV (INFUSION)		RLD, RS	2018-05-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / IV (INFUSION)		RLD, RS	2018-05-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / IV (INFUSION)		RLD, RS	2018-05-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / IV (INFUSION)		RLD, RS	2018-05-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / IV (INFUSION)		RLD, RS	2018-05-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / IV (INFUSION)		RLD, RS	2018-05-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-05-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-05-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-05-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-05-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-05-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / IV (INFUSION)		RLD, RS	2018-05-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / IV (INFUSION)		RLD, RS	2018-05-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / IV (INFUSION)		RLD, RS	2018-05-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / IV (INFUSION)		RLD, RS	2018-05-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / IV (INFUSION)		RLD, RS	2018-05-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / IV (INFUSION)		RLD, RS	2018-05-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / IV (INFUSION)		RLD, RS	2018-05-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / IV (INFUSION)		RLD, RS	2018-05-15	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N205580-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205580-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205580-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205580-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205580-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205580-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205580-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205580-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205580-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205580-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205580-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205580-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205580-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205580-001	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N205580-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N205580-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N205580-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N205580-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N205580-001	AP	1	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N205580-001	AP	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 15 · 562 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N205580-001	8791270	2026-01-12	U-1971	Drug product	2018-08-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205580-001	8791270	2026-01-12	U-1972	Drug product	2018-08-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205580-001	10010533	2031-01-28		Drug product	2018-07-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205580-001	11103483	2031-01-28	U-1971	Drug product	2021-08-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205580-001	11103483	2031-01-28	U-1972	Drug product	2021-08-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205580-001	11844783	2031-01-28	U-1542		2023-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205580-001	11844783	2031-01-28	U-1971		2023-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205580-001	11844783	2031-01-28	U-1972		2023-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205580-001	11872214	2031-01-28		Drug product	2024-01-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205580-001	12138248	2031-01-28		Drug product	2025-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205580-001	12350257	2031-01-28	U-1542	Drug product	2025-07-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205580-001	12350257	2031-01-28	U-1971	Drug product	2025-07-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205580-001	12350257	2031-01-28	U-1972	Drug product	2025-07-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205580-001	9265831	2031-01-28		Drug product	2018-08-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205580-001	9572796	2031-01-28	U-1971	Drug product	2018-08-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205580-001	9572796	2031-01-28	U-1972	Drug product	2018-08-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205580-001	9572797	2031-01-28	U-1972		2018-08-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205580-001	9572797	2031-01-28	U-1971		2018-08-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205580-001	8609707	2031-08-11	U-1971	Drug product	2018-08-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205580-001	8609707	2031-08-11	U-1972	Drug product	2018-08-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205580-001	8791270	2026-01-12	U-1971	Drug product	2018-08-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205580-001	8791270	2026-01-12	U-1972	Drug product	2018-08-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205580-001	10010533	2031-01-28		Drug product	2018-07-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205580-001	11103483	2031-01-28	U-1971	Drug product	2021-08-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205580-001	11103483	2031-01-28	U-1972	Drug product	2021-08-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205580-001	11844783	2031-01-28	U-1542		2023-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205580-001	11844783	2031-01-28	U-1971		2023-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205580-001	11844783	2031-01-28	U-1972		2023-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205580-001	11872214	2031-01-28		Drug product	2024-01-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205580-001	12138248	2031-01-28		Drug product	2025-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205580-001	12350257	2031-01-28	U-1542	Drug product	2025-07-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205580-001	12350257	2031-01-28	U-1971	Drug product	2025-07-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205580-001	12350257	2031-01-28	U-1972	Drug product	2025-07-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205580-001	9265831	2031-01-28		Drug product	2018-08-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205580-001	9572796	2031-01-28	U-1971	Drug product	2018-08-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205580-001	9572796	2031-01-28	U-1972	Drug product	2018-08-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205580-001	9572797	2031-01-28	U-1972		2018-08-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205580-001	9572797	2031-01-28	U-1971		2018-08-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205580-001	8609707	2031-08-11	U-1971	Drug product	2018-08-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205580-001	8609707	2031-08-11	U-1972	Drug product	2018-08-01	`31067a03dcf5…`

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	N205580-001	ODE*	2022-12-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N205580-001	ODE*	2022-12-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N205580-001	ODE*	2022-12-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N205580-001	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BELRAPZO	BENDAMUSTINE HYDROCHLORIDE	Eagle Pharmaceuticals, Inc	9759a4ae-82ca-40cf-9c02-e1cadb21cbdc	2024-09-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205580 application number: NDA205580 ndc (product): 42367-521

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42367-520	BENDAMUSTINE HYDROCHLORIDE	bendamustine hydrochloride	Eagle Pharmaceuticals, Inc	NDA	Current
42367-520	BENDAMUSTINE HYDROCHLORIDE	bendamustine hydrochloride	Eagle Pharmaceuticals, Inc	NDA	Current
42367-521	BELRAPZO	bendamustine hydrochloride	Eagle Pharmaceuticals, Inc	NDA	Current
42367-521	BELRAPZO	bendamustine hydrochloride	Eagle Pharmaceuticals, Inc	NDA	Current
42367-521	BELRAPZO	bendamustine hydrochloride	Eagle Pharmaceuticals, Inc	NDA	Current
42367-521	BELRAPZO	bendamustine hydrochloride	Eagle Pharmaceuticals, Inc	NDA	Current
42367-521	BELRAPZO	bendamustine hydrochloride	Eagle Pharmaceuticals, Inc	NDA	Current
42367-521	BELRAPZO	bendamustine hydrochloride	Eagle Pharmaceuticals, Inc	NDA	Current
42367-521	BELRAPZO	bendamustine hydrochloride	Eagle Pharmaceuticals, Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77227	SUPPL	2024-01-16
77211	SUPPL	2024-01-16
71215	SUPPL	2022-06-06
71207	SUPPL	2022-06-03
69022	SUPPL	2021-10-19
69001	SUPPL	2021-10-15
60756	SUPPL	2019-10-31
60752	SUPPL	2019-10-31
58073	ORIG	2019-03-25
56730	SUPPL	2018-12-13
54313	ORIG	2018-05-23
54226	ORIG	2018-05-23