Application 217110

Type: NDA
Sponsor: APOTEX

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IVRA	MELPHALAN HYDROCHLORIDE	SOLUTION;INTRAVENOUS	EQ 90MG BASE/ML (EQ 90MG BASE/ML)	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
N217110-001	IVRA	MELPHALAN HYDROCHLORIDE	EQ 90MG BASE/ML (EQ 90MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-08-18

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N217110-001	10537520	2036-06-29		Drug product	2023-09-01

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.

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	N217110-001	IVRA	EQ 90MG BASE/ML (EQ 90MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-08-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217110-001	IVRA	EQ 90MG BASE/ML (EQ 90MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-08-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217110-001	IVRA	EQ 90MG BASE/ML (EQ 90MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-08-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217110-001	IVRA	EQ 90MG BASE/ML (EQ 90MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-08-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217110-001	IVRA	EQ 90MG BASE/ML (EQ 90MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-08-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217110-001	IVRA	EQ 90MG BASE/ML (EQ 90MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-08-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217110-001	IVRA	EQ 90MG BASE/ML (EQ 90MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-08-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217110-001	IVRA	EQ 90MG BASE/ML (EQ 90MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-08-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217110-001	IVRA	EQ 90MG BASE/ML (EQ 90MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-08-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217110-001	IVRA	EQ 90MG BASE/ML (EQ 90MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-08-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217110-001	IVRA	EQ 90MG BASE/ML (EQ 90MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-08-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217110-001	IVRA	EQ 90MG BASE/ML (EQ 90MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-08-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217110-001	IVRA	EQ 90MG BASE/ML (EQ 90MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-08-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217110-001	MELPHALAN HYDROCHLORIDE	EQ 90MG BASE/ML (EQ 90MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-08-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217110-001	MELPHALAN HYDROCHLORIDE	EQ 90MG BASE/ML (EQ 90MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-08-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N217110-001	MELPHALAN HYDROCHLORIDE	EQ 90MG BASE/ML (EQ 90MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-08-18	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217110-001	MELPHALAN HYDROCHLORIDE	EQ 90MG BASE/ML (EQ 90MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-08-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N217110-001	MELPHALAN HYDROCHLORIDE	EQ 90MG BASE/ML (EQ 90MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-08-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N217110-001	MELPHALAN HYDROCHLORIDE	EQ 90MG BASE/ML (EQ 90MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-08-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N217110-001	MELPHALAN HYDROCHLORIDE	EQ 90MG BASE/ML (EQ 90MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-08-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N217110-001	MELPHALAN HYDROCHLORIDE	EQ 90MG BASE/ML (EQ 90MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-08-18	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217110-001	IVRA	EQ 90MG BASE/ML (EQ 90MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-08-18	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N217110-001	10537520	2036-06-29	Drug product	2023-09-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217110-001	10537520	2036-06-29	Drug product	2023-09-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217110-001	10537520	2036-06-29	Drug product	2023-09-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217110-001	10537520	2036-06-29	Drug product	2023-09-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217110-001	10537520	2036-06-29	Drug product	2023-09-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217110-001	10537520	2036-06-29	Drug product	2023-09-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217110-001	10537520	2036-06-29	Drug product	2023-09-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217110-001	10537520	2036-06-29	Drug product	2023-09-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217110-001	10537520	2036-06-29	Drug product	2023-09-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217110-001	10537520	2036-06-29	Drug product	2023-09-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217110-001	10537520	2036-06-29	Drug product	2023-09-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217110-001	10537520	2036-06-29	Drug product	2023-09-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217110-001	10537520	2036-06-29	Drug product	2023-09-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217110-001	10537520	2036-06-29	Drug product	2023-09-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217110-001	10537520	2036-06-29	Drug product	2023-09-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N217110-001	10537520	2036-06-29	Drug product	2023-09-01	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217110-001	10537520	2036-06-29	Drug product	2023-09-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N217110-001	10537520	2036-06-29	Drug product	2023-09-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N217110-001	10537520	2036-06-29	Drug product	2023-09-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N217110-001	10537520	2036-06-29	Drug product	2023-09-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N217110-001	10537520	2036-06-29	Drug product	2023-09-01	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217110-001	10537520	2036-06-29	Drug product	2023-09-01	`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 · 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.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79160	SUPPL	2024-07-24
79152	SUPPL	2024-07-23
77472	ORIG	2024-02-12
75222	ORIG	2023-08-22
75221	ORIG	2023-08-22