Application 211463

Type: ANDA
Sponsor: TWI PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MELPHALAN HYDROCHLORIDE	MELPHALAN HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 50MG BASE/VIAL	No	No

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

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
A211463-001	MELPHALAN HYDROCHLORIDE	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP		2019-09-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211463-001	AP

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
2026-08-18 06:07:40	2026-07	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-09-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-09-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-09-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-09-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-09-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-09-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-09-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-09-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-09-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-09-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-09-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-09-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-09-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-09-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-09-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION		2019-09-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION		2019-09-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION		2019-09-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-09-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION		2019-09-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION		2019-09-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION		2019-09-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION		2019-09-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION		2019-09-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION		2019-09-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-09-13	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-09-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-09-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-09-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-09-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-09-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-09-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-09-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-09-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-09-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-09-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-09-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION		2019-09-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION		2019-09-13	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-09-13	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A211463-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211463-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211463-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211463-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211463-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211463-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211463-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211463-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211463-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211463-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211463-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211463-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211463-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211463-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211463-001	AP	1	`8072bd15b7f6…`
2019-12-13 00:20 UTC	2019-12	A211463-001	AP	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A211463-001	AP	1	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211463-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211463-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211463-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211463-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211463-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211463-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211463-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211463-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211463-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211463-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211463-001	AP	1	`f41ea6bd6efb…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211463-001	AP	1	`a50c72e98297…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Melphalan Hydrochloride	MELPHALAN HYDROCHLORIDE	Arthur Group LLC	2254450e-4803-b947-e063-6394a90a4624	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211463 application number: ANDA211463
Melphalan Hydrochloride	MELPHALAN HYDROCHLORIDE	Qilu Pharmaceutical Co., Ltd.	91948ff9-6070-485b-b4b7-3cb477c1b24c	2024-07-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211463 application number: ANDA211463
Melphalan Hydrochloride	MELPHALAN HYDROCHLORIDE	Avenacy Inc.	8edd78a9-d762-4578-a610-28d6595f4bf3	2023-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211463 application number: ANDA211463