Application 207155

Type: NDA
Sponsor: ACROTECH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EVOMELA	MELPHALAN HYDROCHLORIDE	POWDER;INTRAVENOUS	EQ 50MG BASE/VIAL	Yes	Yes

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

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
N207155-001	EVOMELA	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS		RLD, RS	2016-03-10

Orange Book patents#

Current patent rows page 1 of 1 · 7 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N207155-001	8410077	2029-03-13		Drug product	2016-04-05
N207155-001	9200088	2029-03-13		Drug product	2016-04-05
N207155-001	10864183	2030-05-28		Drug product	2020-12-15
N207155-001	11020363	2030-05-28		Drug product	2021-06-10
N207155-001	10940128	2030-06-14	U-3086	Drug product	2021-03-19
N207155-001	9493582	2033-02-27		Drug product	2017-03-14
N207155-001	10040872	2034-01-30		Drug product	2018-09-06

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N207155-001	EVOMELA	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2016-03-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N207155-001	EVOMELA	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2016-03-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N207155-001	EVOMELA	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2016-03-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207155-001	EVOMELA	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2016-03-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207155-001	EVOMELA	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2016-03-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207155-001	EVOMELA	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2016-03-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207155-001	EVOMELA	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2016-03-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207155-001	EVOMELA	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2016-03-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207155-001	EVOMELA	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2016-03-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207155-001	EVOMELA	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2016-03-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207155-001	EVOMELA	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2016-03-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N207155-001	EVOMELA	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2016-03-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207155-001	EVOMELA	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2016-03-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207155-001	EVOMELA	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2016-03-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207155-001	EVOMELA	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2016-03-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N207155-001	EVOMELA	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2016-03-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207155-001	EVOMELA	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2016-03-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N207155-001	EVOMELA	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2016-03-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N207155-001	EVOMELA	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2016-03-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N207155-001	EVOMELA	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2016-03-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N207155-001	EVOMELA	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2016-03-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N207155-001	EVOMELA	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2016-03-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N207155-001	EVOMELA	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2016-03-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N207155-001	EVOMELA	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2016-03-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N207155-001	EVOMELA	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2016-03-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N207155-001	EVOMELA	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2016-03-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N207155-001	EVOMELA	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2016-03-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N207155-001	EVOMELA	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2016-03-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N207155-001	EVOMELA	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2016-03-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N207155-001	EVOMELA	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2016-03-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N207155-001	EVOMELA	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2016-03-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N207155-001	EVOMELA	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2016-03-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N207155-001	EVOMELA	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2016-03-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N207155-001	EVOMELA	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2016-03-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N207155-001	EVOMELA	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2016-03-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N207155-001	EVOMELA	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2016-03-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N207155-001	EVOMELA	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2016-03-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N207155-001	EVOMELA	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2016-03-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N207155-001	EVOMELA	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2016-03-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N207155-001	EVOMELA	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2016-03-10	`f41ea6bd6efb…`

Observed Orange Book patent history#

Patent history page 1 of 7 · 280 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	N207155-001	8410077	2029-03-13		Drug product	2016-04-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207155-001	9200088	2029-03-13		Drug product	2016-04-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207155-001	10864183	2030-05-28		Drug product	2020-12-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207155-001	11020363	2030-05-28		Drug product	2021-06-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207155-001	10940128	2030-06-14	U-3086	Drug product	2021-03-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207155-001	9493582	2033-02-27		Drug product	2017-03-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207155-001	10040872	2034-01-30		Drug product	2018-09-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N207155-001	8410077	2029-03-13		Drug product	2016-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207155-001	9200088	2029-03-13		Drug product	2016-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207155-001	10864183	2030-05-28		Drug product	2020-12-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207155-001	11020363	2030-05-28		Drug product	2021-06-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207155-001	10940128	2030-06-14	U-3086	Drug product	2021-03-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207155-001	9493582	2033-02-27		Drug product	2017-03-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207155-001	10040872	2034-01-30		Drug product	2018-09-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N207155-001	8410077	2029-03-13		Drug product	2016-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207155-001	9200088	2029-03-13		Drug product	2016-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207155-001	10864183	2030-05-28		Drug product	2020-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207155-001	11020363	2030-05-28		Drug product	2021-06-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207155-001	10940128	2030-06-14	U-3086	Drug product	2021-03-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207155-001	9493582	2033-02-27		Drug product	2017-03-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207155-001	10040872	2034-01-30		Drug product	2018-09-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207155-001	8410077	2029-03-13		Drug product	2016-04-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207155-001	9200088	2029-03-13		Drug product	2016-04-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207155-001	10864183	2030-05-28		Drug product	2020-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207155-001	11020363	2030-05-28		Drug product	2021-06-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207155-001	10940128	2030-06-14	U-3086	Drug product	2021-03-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207155-001	9493582	2033-02-27		Drug product	2017-03-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207155-001	10040872	2034-01-30		Drug product	2018-09-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207155-001	8410077	2029-03-13		Drug product	2016-04-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207155-001	9200088	2029-03-13		Drug product	2016-04-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207155-001	10864183	2030-05-28		Drug product	2020-12-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207155-001	11020363	2030-05-28		Drug product	2021-06-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207155-001	10940128	2030-06-14	U-3086	Drug product	2021-03-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207155-001	9493582	2033-02-27		Drug product	2017-03-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207155-001	10040872	2034-01-30		Drug product	2018-09-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207155-001	8410077	2029-03-13		Drug product	2016-04-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207155-001	9200088	2029-03-13		Drug product	2016-04-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207155-001	10864183	2030-05-28		Drug product	2020-12-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207155-001	11020363	2030-05-28		Drug product	2021-06-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207155-001	10940128	2030-06-14	U-3086	Drug product	2021-03-19	`fd3edfee7708…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207155-001	ODE-110	2023-03-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N207155-001	ODE-110	2023-03-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N207155-001	ODE-110	2023-03-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N207155-001	ODE-110	2023-03-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N207155-001	ODE-110	2023-03-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N207155-001	ODE-110	2023-03-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N207155-001	ODE-110	2023-03-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N207155-001	ODE-110	2023-03-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N207155-001	ODE-110	2023-03-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N207155-001	ODE-110	2023-03-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N207155-001	ODE-110	2023-03-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N207155-001	ODE-110	2023-03-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N207155-001	ODE-110	2023-03-10	`ea99ee380514…`
2023-12-20 04:57 UTC	2023-12	N207155-001	ODE-110	2023-03-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N207155-001	ODE-110	2023-03-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N207155-001	ODE-110	2023-03-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N207155-001	ODE-110	2023-03-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N207155-001	ODE-110	2023-03-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N207155-001	ODE-110	2023-03-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N207155-001	ODE-110	2023-03-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N207155-001	ODE-110	2023-03-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N207155-001	ODE-110	2023-03-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N207155-001	ODE-110	2023-03-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N207155-001	ODE-110	2023-03-10	`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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Melphalan hydrochloride	MELPHALAN HYDROCHLORIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	2c18beeb-7bd4-4591-94cb-9d7156c1b8e0	2026-07-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MELPHALAN HYDROCHLORIDE
Melphalan	MELPHALAN HYDROCHLORIDE	Fresenius Kabi USA, LLC	e9c2efee-173d-4795-96d8-7aae5b3a3073	2026-01-14	Warnings, Adverse reactions	Name fallback generic name: MELPHALAN HYDROCHLORIDE
Melphalan Hydrochloride	MELPHALAN HYDROCHLORIDE	Arthur Group LLC	2254450e-4803-b947-e063-6394a90a4624	2026-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MELPHALAN HYDROCHLORIDE
Melphalan hydrochloride	MELPHALAN HYDROCHLORIDE	BPI Labs LLC	dab93975-0587-4f12-848c-9130bb02d036	2025-12-05	Warnings, Adverse reactions	Name fallback generic name: MELPHALAN HYDROCHLORIDE
Melphalan Hydrochloride	MELPHALAN HYDROCHLORIDE	Qilu Pharmaceutical Co., Ltd.	91948ff9-6070-485b-b4b7-3cb477c1b24c	2024-07-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MELPHALAN HYDROCHLORIDE
MELPHALAN HYDROCHLORIDE	MELPHALAN HYDROCHLORIDE	Camber Pharmaceuticals, Inc.	24006cbf-4e91-4bb2-9627-25b4ebc9470a	2024-06-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MELPHALAN HYDROCHLORIDE
Melphalan Hydrochloride	MELPHALAN HYDROCHLORIDE	Sagent Pharmaceuticals	35f3d9fe-3c2f-4362-9d40-cdab014cac38	2024-03-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MELPHALAN HYDROCHLORIDE
Melphalan Hydrochloride	MELPHALAN HYDROCHLORIDE	Dr.Reddy's Laboratories Inc	bd5e4db5-8787-4428-2cb6-ef6f8a5e08af	2024-02-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MELPHALAN HYDROCHLORIDE
Melphalan Hydrochloride	MELPHALAN HYDROCHLORIDE	Avenacy Inc.	8edd78a9-d762-4578-a610-28d6595f4bf3	2023-12-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MELPHALAN HYDROCHLORIDE
Melphalan hydrochloride	MELPHALAN HYDROCHLORIDE	Meitheal Pharmaceuticals Inc.	d99b3865-e0f0-482a-9ec6-da642e5104ea	2021-06-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MELPHALAN HYDROCHLORIDE
Melphalan Hydrochloride	MELPHALAN HYDROCHLORIDE	Mylan Institutional LLC	a8bf1877-fd06-4ef6-b82d-fe0ff1956bde	2020-09-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MELPHALAN HYDROCHLORIDE
Melphalan hydrochloride	MELPHALAN HYDROCHLORIDE	Fosun Pharma USA Inc	54712714-744d-4deb-83b2-694da49a9272	2019-07-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MELPHALAN HYDROCHLORIDE
Melphalan hydrochloride	MELPHALAN HYDROCHLORIDE	Gland Pharma Limited	ea7fbf4e-4980-4bb4-bac9-99eb6f633ba0	2019-06-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MELPHALAN HYDROCHLORIDE
Melphalan Hydrochloride	MELPHALAN HYDROCHLORIDE	Dr.Reddy's Laboratories Inc	d4705154-3050-1a5c-950f-e24b51487401	2018-04-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MELPHALAN 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 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68152-109	EVOMELA	Melphalan	Spectrum Pharmaceuticals, Inc.	NDA	Current
68152-109	EVOMELA	Melphalan	Spectrum Pharmaceuticals, Inc.	NDA	Current
68152-109	EVOMELA	Melphalan	Spectrum Pharmaceuticals, Inc.	NDA	Current
68152-109	EVOMELA	Melphalan	Spectrum Pharmaceuticals, Inc.	NDA	Current
68152-109	EVOMELA	Melphalan	Acrotech Biopharma LLC	NDA	Current
69605-001	EVOMELA	Melphalan	CENEXI - BLA	NDA	Current
72893-001	EVOMELA	Melphalan	Acrotech Biopharma LLC	NDA	Current
72893-001	EVOMELA	Melphalan	Acrotech Biopharma LLC	NDA	Current
72893-001	EVOMELA	Melphalan	Acrotech Biopharma LLC	NDA	Current
72893-001	EVOMELA	Melphalan	Acrotech Biopharma LLC	NDA	Current
72893-001	EVOMELA	Melphalan	Acrotech Biopharma LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
70948	SUPPL	2022-05-03
70820	SUPPL	2022-04-27
68345	SUPPL	2021-08-11
68326	SUPPL	2021-08-10
50934	SUPPL	2017-12-27
46006	ORIG	2016-12-02
46005	ORIG	2016-12-02
19960	ORIG	2016-03-15
32849	ORIG	2016-03-14