Application 018565

Type: NDA
Sponsor: HIKMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DURAMORPH PF	MORPHINE SULFATE	INJECTABLE;INJECTION	0.5MG/ML	Yes	Yes
002	DURAMORPH PF	MORPHINE SULFATE	INJECTABLE;INJECTION	1MG/ML	Yes	Yes
003	INFUMORPH	MORPHINE SULFATE	INJECTABLE;INJECTION	10MG/ML	Yes	Yes
004	INFUMORPH	MORPHINE SULFATE	INJECTABLE;INJECTION	25MG/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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N018565-001	DURAMORPH PF	MORPHINE SULFATE	0.5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1984-09-18
N018565-002	DURAMORPH PF	MORPHINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1984-09-18
N018565-003	INFUMORPH	MORPHINE SULFATE	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-07-19
N018565-004	INFUMORPH	MORPHINE SULFATE	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-07-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N018565-001	AP
N018565-002	AP
N018565-003	AP
N018565-004	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.

Product history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N018565-001	DURAMORPH PF	0.5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1984-09-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018565-002	DURAMORPH PF	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1984-09-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018565-003	INFUMORPH	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018565-004	INFUMORPH	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-07-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018565-001	DURAMORPH PF	0.5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1984-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018565-002	DURAMORPH PF	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1984-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018565-003	INFUMORPH	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018565-004	INFUMORPH	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-07-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018565-001	DURAMORPH PF	0.5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1984-09-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018565-002	DURAMORPH PF	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1984-09-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018565-003	INFUMORPH	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018565-004	INFUMORPH	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-07-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018565-001	DURAMORPH PF	0.5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1984-09-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018565-002	DURAMORPH PF	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1984-09-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018565-003	INFUMORPH	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018565-004	INFUMORPH	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-07-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018565-001	DURAMORPH PF	0.5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1984-09-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018565-002	DURAMORPH PF	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1984-09-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018565-003	INFUMORPH	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018565-004	INFUMORPH	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-07-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018565-001	DURAMORPH PF	0.5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1984-09-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018565-002	DURAMORPH PF	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1984-09-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018565-003	INFUMORPH	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018565-004	INFUMORPH	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-07-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018565-001	DURAMORPH PF	0.5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1984-09-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018565-002	DURAMORPH PF	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1984-09-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018565-003	INFUMORPH	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-07-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018565-004	INFUMORPH	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-07-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018565-001	DURAMORPH PF	0.5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1984-09-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018565-002	DURAMORPH PF	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1984-09-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018565-003	INFUMORPH	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-07-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018565-004	INFUMORPH	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-07-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018565-001	DURAMORPH PF	0.5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1984-09-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018565-002	DURAMORPH PF	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1984-09-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018565-003	INFUMORPH	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-07-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018565-004	INFUMORPH	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-07-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018565-001	DURAMORPH PF	0.5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1984-09-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018565-002	DURAMORPH PF	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1984-09-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018565-003	INFUMORPH	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-07-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018565-004	INFUMORPH	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-07-19	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N018565-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018565-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018565-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018565-004	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018565-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018565-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018565-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018565-004	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018565-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018565-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018565-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018565-004	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018565-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018565-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018565-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018565-004	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018565-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018565-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018565-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018565-004	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018565-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018565-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018565-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018565-004	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018565-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018565-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018565-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018565-004	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018565-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018565-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018565-003	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018565-004	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018565-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018565-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018565-003	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018565-004	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018565-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018565-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018565-003	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018565-004	AP	1	`d8e5a09893c0…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Duramorph	MORPHINE SULFATE	Hikma Pharmaceuticals USA Inc.	ebb18761-e5c4-4238-bb84-f9549f500210	2025-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018565 application number: NDA018565 ndc (product): 0641-6020 ndc (product): 0641-6019
INFUMORPH 200	MORPHINE SULFATE	Hikma Pharmaceuticals USA Inc.	db9ac9e3-d761-4a99-9f34-4946ebe8f255	2025-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018565 application number: NDA018565 ndc (product): 0641-6040 ndc (product): 0641-6039

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0641-6019	Duramorph	morphine sulfate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-6019	Duramorph	morphine sulfate	West-Ward Pharmaceuticals Corp.	NDA	Current
0641-6019	Duramorph	morphine sulfate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-6019	Duramorph	morphine sulfate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-6020	Duramorph	morphine sulfate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-6020	Duramorph	morphine sulfate	West-Ward Pharmaceuticals Corp.	NDA	Current
0641-6020	Duramorph	morphine sulfate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-6020	Duramorph	morphine sulfate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-6039	INFUMORPH 200	morphine sulfate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-6039	INFUMORPH 200	morphine sulfate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-6039	INFUMORPH 200	morphine sulfate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-6039	INFUMORPH 200	morphine sulfate	West-Ward Pharmaceuticals Corp.	NDA	Current
0641-6040	INFUMORPH 500	morphine sulfate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-6040	INFUMORPH 500	morphine sulfate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-6040	INFUMORPH 500	morphine sulfate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-6040	INFUMORPH 500	morphine sulfate	West-Ward Pharmaceuticals Corp.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84649	SUPPL	2026-01-06
84648	SUPPL	2026-01-06
84557	SUPPL	2025-12-29
84556	SUPPL	2025-12-29
77037	SUPPL	2023-12-19
77036	SUPPL	2023-12-19
77035	SUPPL	2023-12-19
77034	SUPPL	2023-12-19
76974	SUPPL	2023-12-18
76973	SUPPL	2023-12-18
76951	SUPPL	2023-12-18
76950	SUPPL	2023-12-18
76554	SUPPL	2023-11-13
76546	SUPPL	2023-11-13
60414	SUPPL	2019-10-09
60276	SUPPL	2019-10-07
46509	SUPPL	2016-12-23
46489	SUPPL	2016-12-22
46403	SUPPL	2016-12-21
46220	SUPPL	2016-12-19
11239	SUPPL	2010-10-12
950	SUPPL	2010-10-05
33506	SUPPL	2009-05-19
11238	SUPPL	2005-06-08
949	SUPPL	2005-06-08
15032	SUPPL	2004-06-01
948	SUPPL	2003-07-06