Application 217812

Type: NDA
Sponsor: HIKMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	40MG/20ML (2MG/ML)	Yes	Yes

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
N217812-001	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2023-12-14

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
N217812-001	12653820	2043-01-10	U-4571	Drug product	2026-07-14

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
2026-08-18 06:07:40	2026-07	N217812-001	HYDROMORPHONE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	2023-12-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217812-001	HYDROMORPHONE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	2023-12-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217812-001	HYDROMORPHONE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	2023-12-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217812-001	HYDROMORPHONE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	2023-12-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217812-001	HYDROMORPHONE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	2023-12-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217812-001	HYDROMORPHONE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	2023-12-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217812-001	HYDROMORPHONE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	2023-12-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217812-001	HYDROMORPHONE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	2023-12-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217812-001	HYDROMORPHONE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	2023-12-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217812-001	HYDROMORPHONE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	2023-12-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217812-001	HYDROMORPHONE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	2023-12-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217812-001	HYDROMORPHONE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	2023-12-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217812-001	HYDROMORPHONE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	2023-12-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217812-001	HYDROMORPHONE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	2023-12-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N217812-001	HYDROMORPHONE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	2023-12-14	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217812-001	HYDROMORPHONE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	2023-12-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N217812-001	HYDROMORPHONE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	2023-12-14	`1c564ffb4f44…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217812-001	HYDROMORPHONE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	2023-12-14	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N217812-001	12653820	2043-01-10	U-4571	Drug product	2026-07-14	`caaa826d4ba7…`

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
Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	c729424e-e483-4bf8-b86c-ce56636dcffa	2025-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 217812 application number: NDA217812

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84702	SUPPL	2026-01-07
84588	SUPPL	2025-12-29
79819	ORIG	2024-10-07
76858	ORIG	2023-12-15
76844	ORIG	2023-12-15