Application 215320

Type: NDA
Sponsor: HIKMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	COMBOGESIC IV	ACETAMINOPHEN; IBUPROFEN SODIUM	SOLUTION;INTRAVENOUS	1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG 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
N215320-001	COMBOGESIC IV	ACETAMINOPHEN; IBUPROFEN SODIUM	1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-10-17

Orange Book patents#

Current patent rows page 1 of 1 · 10 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N215320-001	11446266	2031-10-26	U-3744		2023-11-16
N215320-001	11446266	2031-10-26	U-3745		2023-11-16
N215320-001	11896567	2031-10-26	U-3744		2024-03-12
N215320-001	11896567	2031-10-26	U-3745		2024-03-12
N215320-001	12220392	2031-10-26	U-4306		2025-11-06
N215320-001	12220392	2031-10-26	U-4307		2025-11-06
N215320-001	11389416	2035-07-17		Drug product	2023-11-16
N215320-001	12083087	2035-07-17	U-3744		2024-10-08
N215320-001	12083087	2035-07-17	U-3745		2024-10-08
N215320-001	11213498	2036-01-14		Drug product	2023-11-16

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N215320-001	NP	2026-10-17

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	N215320-001	COMBOGESIC IV	1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-10-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215320-001	COMBOGESIC IV	1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-10-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215320-001	COMBOGESIC IV	1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-10-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215320-001	COMBOGESIC IV	1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-10-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215320-001	COMBOGESIC IV	1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-10-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215320-001	COMBOGESIC IV	1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-10-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215320-001	COMBOGESIC IV	1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-10-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215320-001	COMBOGESIC IV	1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-10-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215320-001	COMBOGESIC IV	1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-10-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215320-001	COMBOGESIC IV	1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-10-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215320-001	COMBOGESIC IV	1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-10-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215320-001	COMBOGESIC IV	1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-10-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215320-001	COMBOGESIC IV	1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-10-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215320-001	COMBOGESIC IV	1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-10-17	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215320-001	COMBOGESIC IV	1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-10-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215320-001	COMBOGESIC IV	1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-10-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215320-001	COMBOGESIC IV	1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-10-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215320-001	COMBOGESIC IV	1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-10-17	`a72a2bbeb626…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215320-001	COMBOGESIC IV	1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-10-17	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 128 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N215320-001	11446266	2031-10-26	U-3744		2023-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215320-001	11446266	2031-10-26	U-3745		2023-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215320-001	11896567	2031-10-26	U-3744		2024-03-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215320-001	11896567	2031-10-26	U-3745		2024-03-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215320-001	12220392	2031-10-26	U-4306		2025-11-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215320-001	12220392	2031-10-26	U-4307		2025-11-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215320-001	11389416	2035-07-17		Drug product	2023-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215320-001	12083087	2035-07-17	U-3744		2024-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215320-001	12083087	2035-07-17	U-3745		2024-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215320-001	11213498	2036-01-14		Drug product	2023-11-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215320-001	11446266	2031-10-26	U-3744		2023-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215320-001	11446266	2031-10-26	U-3745		2023-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215320-001	11896567	2031-10-26	U-3744		2024-03-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215320-001	11896567	2031-10-26	U-3745		2024-03-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215320-001	12220392	2031-10-26	U-4306		2025-11-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215320-001	12220392	2031-10-26	U-4307		2025-11-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215320-001	11389416	2035-07-17		Drug product	2023-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215320-001	12083087	2035-07-17	U-3744		2024-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215320-001	12083087	2035-07-17	U-3745		2024-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215320-001	11213498	2036-01-14		Drug product	2023-11-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215320-001	11446266	2031-10-26	U-3744		2023-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215320-001	11446266	2031-10-26	U-3745		2023-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215320-001	11896567	2031-10-26	U-3744		2024-03-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215320-001	11896567	2031-10-26	U-3745		2024-03-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215320-001	11389416	2035-07-17		Drug product	2023-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215320-001	12083087	2035-07-17	U-3744		2024-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215320-001	12083087	2035-07-17	U-3745		2024-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215320-001	11213498	2036-01-14		Drug product	2023-11-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215320-001	11446266	2031-10-26	U-3744		2023-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215320-001	11446266	2031-10-26	U-3745		2023-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215320-001	11896567	2031-10-26	U-3744		2024-03-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215320-001	11896567	2031-10-26	U-3745		2024-03-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215320-001	11389416	2035-07-17		Drug product	2023-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215320-001	12083087	2035-07-17	U-3744		2024-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215320-001	12083087	2035-07-17	U-3745		2024-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215320-001	11213498	2036-01-14		Drug product	2023-11-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215320-001	11446266	2031-10-26	U-3744		2023-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215320-001	11446266	2031-10-26	U-3745		2023-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215320-001	11896567	2031-10-26	U-3744		2024-03-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215320-001	11896567	2031-10-26	U-3745		2024-03-12	`b8a1b40f171c…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N215320-001	NP	2026-10-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215320-001	NP	2026-10-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215320-001	NP	2026-10-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215320-001	NP	2026-10-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215320-001	NP	2026-10-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215320-001	NP	2026-10-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215320-001	NP	2026-10-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215320-001	NP	2026-10-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215320-001	NP	2026-10-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215320-001	NP	2026-10-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215320-001	NP	2026-10-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215320-001	NP	2026-10-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215320-001	NP	2026-10-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215320-001	NP	2026-10-17	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215320-001	NP	2026-10-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215320-001	NP	2026-10-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215320-001	NP	2026-10-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215320-001	NP	2026-10-17	`a72a2bbeb626…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215320-001	NP	2026-10-17	`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
COMBOGESIC IV	ACETAMINOPHEN AND IBUPROFEN INJECTION	Hikma Pharmaceuticals USA Inc.	be408a5a-48e4-43c0-9cb1-bbf830b54f5b	2024-11-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 215320 application number: NDA215320

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80359	SUPPL	2024-11-25
80349	SUPPL	2024-11-25
79703	ORIG	2024-09-23
75883	ORIG	2023-10-20
75838	ORIG	2023-10-18