Application 212045

Type: NDA
Sponsor: HIKMA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KLOXXADO	NALOXONE HYDROCHLORIDE	SPRAY;NASAL	8MG	No	No
002	KLOXXADO	NALOXONE HYDROCHLORIDE	SPRAY;NASAL	4MG/SPRAY	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N212045-001	KLOXXADO	NALOXONE HYDROCHLORIDE	8MG/SPRAY	SPRAY / NASAL		RLD, RS	2021-04-29
N212045-002	KLOXXADO	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY / NASAL		RLD	2025-08-25

Orange Book patents#

Current patent rows page 1 of 1 · 7 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N212045-001	10722510	2034-08-26	U-3110	Drug product	2021-05-19
N212045-001	10973814	2034-08-26	U-3110	Drug product	2021-05-19
N212045-001	11135155	2034-08-26		Drug product	2022-03-29
N212045-001	11617713	2034-08-26	U-3110	Drug product	2023-04-28
N212045-001	11628139	2034-08-26	U-3110	Drug product	2023-04-28
N212045-001	11975096	2034-08-26		Drug product	2024-12-04
N212045-001	12414915	2034-08-26		Drug product	2025-09-30

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	N212045-001	KLOXXADO	8MG/SPRAY	SPRAY / NASAL	RLD, RS	2021-04-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212045-002	KLOXXADO	4MG/SPRAY	SPRAY / NASAL	RLD	2025-08-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212045-001	KLOXXADO	8MG/SPRAY	SPRAY / NASAL	RLD, RS	2021-04-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212045-002	KLOXXADO	4MG/SPRAY	SPRAY / NASAL	RLD	2025-08-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212045-001	KLOXXADO	8MG/SPRAY	SPRAY / NASAL	RLD, RS	2021-04-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212045-001	KLOXXADO	8MG/SPRAY	SPRAY / NASAL	RLD, RS	2021-04-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212045-001	KLOXXADO	8MG/SPRAY	SPRAY / NASAL	RLD, RS	2021-04-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212045-001	KLOXXADO	8MG/SPRAY	SPRAY / NASAL	RLD, RS	2021-04-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212045-001	KLOXXADO	8MG/SPRAY	SPRAY / NASAL	RLD, RS	2021-04-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212045-001	KLOXXADO	8MG/SPRAY	SPRAY / NASAL	RLD, RS	2021-04-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212045-001	KLOXXADO	8MG/SPRAY	SPRAY / NASAL	RLD, RS	2021-04-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212045-001	KLOXXADO	8MG/SPRAY	SPRAY / NASAL	RLD, RS	2021-04-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212045-001	KLOXXADO	8MG/SPRAY	SPRAY / NASAL	RLD, RS	2021-04-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212045-001	KLOXXADO	8MG/SPRAY	SPRAY / NASAL	RLD, RS	2021-04-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212045-001	KLOXXADO	8MG/SPRAY	SPRAY / NASAL	RLD, RS	2021-04-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N212045-001	KLOXXADO	8MG/SPRAY	SPRAY / NASAL	RLD, RS	2021-04-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212045-001	KLOXXADO	8MG/SPRAY	SPRAY / NASAL	RLD, RS	2021-04-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N212045-001	KLOXXADO	8MG/SPRAY	SPRAY / NASAL	RLD, RS	2021-04-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N212045-001	KLOXXADO	8MG/SPRAY	SPRAY / NASAL	RLD, RS	2021-04-29	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N212045-001	KLOXXADO	8MG/SPRAY	SPRAY / NASAL	RLD, RS	2021-04-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N212045-001	KLOXXADO	8MG/SPRAY	SPRAY / NASAL	RLD, RS	2021-04-29	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N212045-001	KLOXXADO	8MG/SPRAY	SPRAY / NASAL	RLD, RS	2021-04-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N212045-001	KLOXXADO	8MG/SPRAY	SPRAY / NASAL	RLD, RS	2021-04-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N212045-001	KLOXXADO	8MG/SPRAY	SPRAY / NASAL	RLD, RS	2021-04-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N212045-001	KLOXXADO	8MG/SPRAY	SPRAY / NASAL	RLD, RS	2021-04-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N212045-001	KLOXXADO	8MG/SPRAY	SPRAY / NASAL	RLD, RS	2021-04-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N212045-001	KLOXXADO	8MG/SPRAY	SPRAY / NASAL	RLD, RS	2021-04-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N212045-001	KLOXXADO	8MG/SPRAY	SPRAY / NASAL	RLD, RS	2021-04-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N212045-001	KLOXXADO	8MG/SPRAY	SPRAY / NASAL	RLD, RS	2021-04-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N212045-001	KLOXXADO	8MG/SPRAY	SPRAY / NASAL	RLD, RS	2021-04-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N212045-001	KLOXXADO	8MG/SPRAY	SPRAY / NASAL	RLD, RS	2021-04-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N212045-001	KLOXXADO	8MG/SPRAY	SPRAY / NASAL	RLD, RS	2021-04-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N212045-001	KLOXXADO	8MG/SPRAY	SPRAY / NASAL	RLD, RS	2021-04-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N212045-001	KLOXXADO	8MG/SPRAY	SPRAY / NASAL	RLD, RS	2021-04-29	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N212045-001	KLOXXADO	8MG/SPRAY	SPRAY / NASAL	RLD, RS	2021-04-29	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N212045-002	KLOXXADO	4MG/SPRAY	SPRAY / NASAL	RLD	2025-08-25	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 151 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	N212045-001	10722510	2034-08-26	U-3110	Drug product	2021-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212045-001	10973814	2034-08-26	U-3110	Drug product	2021-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212045-001	11135155	2034-08-26		Drug product	2022-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212045-001	11617713	2034-08-26	U-3110	Drug product	2023-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212045-001	11628139	2034-08-26	U-3110	Drug product	2023-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212045-001	11975096	2034-08-26		Drug product	2024-12-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212045-001	12414915	2034-08-26		Drug product	2025-09-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212045-001	10722510	2034-08-26	U-3110	Drug product	2021-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212045-001	10973814	2034-08-26	U-3110	Drug product	2021-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212045-001	11135155	2034-08-26		Drug product	2022-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212045-001	11617713	2034-08-26	U-3110	Drug product	2023-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212045-001	11628139	2034-08-26	U-3110	Drug product	2023-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212045-001	11975096	2034-08-26		Drug product	2024-12-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212045-001	12414915	2034-08-26		Drug product	2025-09-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212045-001	10722510	2034-08-26	U-3110	Drug product	2021-05-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212045-001	10973814	2034-08-26	U-3110	Drug product	2021-05-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212045-001	11135155	2034-08-26		Drug product	2022-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212045-001	11617713	2034-08-26	U-3110	Drug product	2023-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212045-001	11628139	2034-08-26	U-3110	Drug product	2023-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212045-001	11975096	2034-08-26		Drug product	2024-12-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212045-001	10722510	2034-08-26	U-3110	Drug product	2021-05-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212045-001	10973814	2034-08-26	U-3110	Drug product	2021-05-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212045-001	11135155	2034-08-26		Drug product	2022-03-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212045-001	11617713	2034-08-26	U-3110	Drug product	2023-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212045-001	11628139	2034-08-26	U-3110	Drug product	2023-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212045-001	11975096	2034-08-26		Drug product	2024-12-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212045-001	10722510	2034-08-26	U-3110	Drug product	2021-05-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212045-001	10973814	2034-08-26	U-3110	Drug product	2021-05-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212045-001	11135155	2034-08-26		Drug product	2022-03-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212045-001	11617713	2034-08-26	U-3110	Drug product	2023-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212045-001	11628139	2034-08-26	U-3110	Drug product	2023-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212045-001	11975096	2034-08-26		Drug product	2024-12-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212045-001	10722510	2034-08-26	U-3110	Drug product	2021-05-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212045-001	10973814	2034-08-26	U-3110	Drug product	2021-05-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212045-001	11135155	2034-08-26		Drug product	2022-03-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212045-001	11617713	2034-08-26	U-3110	Drug product	2023-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212045-001	11628139	2034-08-26	U-3110	Drug product	2023-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212045-001	11975096	2034-08-26		Drug product	2024-12-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212045-001	10722510	2034-08-26	U-3110	Drug product	2021-05-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212045-001	10973814	2034-08-26	U-3110	Drug product	2021-05-19	`2680178bc6a6…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212045-001	NP	2024-04-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212045-001	NP	2024-04-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212045-001	NP	2024-04-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212045-001	NP	2024-04-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212045-001	NP	2024-04-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212045-001	NP	2024-04-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212045-001	NP	2024-04-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212045-001	NP	2024-04-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N212045-001	NP	2024-04-29	`8072bd15b7f6…`

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
KLOXXADO	NALOXONE HCL	Hikma Specialty USA Inc.	ebf0f833-c1c0-487c-8f29-01fa8c61b6cb	2025-08-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 212045 application number: NDA212045 ndc (product): 59467-679

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59467-679	KLOXXADO	Naloxone HCL	Hikma Specialty USA Inc.	NDA	Current
59467-679	KLOXXADO	Naloxone HCL	Hikma Specialty USA Inc.	NDA	Current
59467-679	KLOXXADO	Naloxone HCL	Hikma Specialty USA Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83211	SUPPL	2025-08-27
83197	SUPPL	2025-08-26
68889	ORIG	2021-10-05
67307	ORIG	2021-04-30
67279	ORIG	2021-04-30