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 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
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
2026-02-19 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
2026-02-19 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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
IVRA	MELPHALAN HCL	Apotex Corp	c23e868a-dc62-2181-5099-76c9226602b2	2025-09-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 217110 application number: NDA217110

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