Application 022549

Type: NDA
Sponsor: ALEXZA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ADASUVE	LOXAPINE	POWDER;INHALATION	10MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N022549-001	ADASUVE	LOXAPINE	10MG	POWDER / INHALATION		RLD, RS	2012-12-21

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
N022549-001	8387612	2026-10-23		Drug product	2013-03-29

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 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N022549-001	ADASUVE	10MG	POWDER / INHALATION	RLD, RS	2012-12-21	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N022549-001	ADASUVE	10MG	POWDER / INHALATION	RLD, RS	2012-12-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022549-001	ADASUVE	10MG	POWDER / INHALATION	RLD, RS	2012-12-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022549-001	ADASUVE	10MG	POWDER / INHALATION	RLD, RS	2012-12-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022549-001	ADASUVE	10MG	POWDER / INHALATION	RLD, RS	2012-12-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022549-001	ADASUVE	10MG	POWDER / INHALATION	RLD, RS	2012-12-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022549-001	ADASUVE	10MG	POWDER / INHALATION	RLD, RS	2012-12-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022549-001	ADASUVE	10MG	POWDER / INHALATION	RLD, RS	2012-12-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022549-001	ADASUVE	10MG	POWDER / INHALATION	RLD, RS	2012-12-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022549-001	ADASUVE	10MG	POWDER / INHALATION	RLD, RS	2012-12-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022549-001	ADASUVE	10MG	POWDER / INHALATION	RLD, RS	2012-12-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022549-001	ADASUVE	10MG	POWDER / INHALATION	RLD, RS	2012-12-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022549-001	ADASUVE	10MG	POWDER / INHALATION	RLD, RS	2012-12-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022549-001	ADASUVE	10MG	POWDER / INHALATION	RLD, RS	2012-12-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022549-001	ADASUVE	10MG	POWDER / INHALATION	RLD, RS	2012-12-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022549-001	ADASUVE	10MG	POWDER / INHALATION	RLD, RS	2012-12-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022549-001	ADASUVE	10MG	POWDER / INHALATION	RLD, RS	2012-12-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022549-001	ADASUVE	10MG	POWDER / INHALATION	RLD, RS	2012-12-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022549-001	ADASUVE	10MG	POWDER / INHALATION	RLD, RS	2012-12-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022549-001	ADASUVE	10MG	POWDER / INHALATION	RLD, RS	2012-12-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022549-001	ADASUVE	10MG	POWDER / INHALATION	RLD, RS	2012-12-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022549-001	ADASUVE	10MG	POWDER / INHALATION	RLD, RS	2012-12-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022549-001	ADASUVE	10MG	POWDER / INHALATION	RLD, RS	2012-12-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022549-001	ADASUVE	10MG	POWDER / INHALATION	RLD, RS	2012-12-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022549-001	ADASUVE	10MG	POWDER / INHALATION	RLD, RS	2012-12-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022549-001	ADASUVE	10MG	POWDER / INHALATION	RLD, RS	2012-12-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022549-001	ADASUVE	10MG	POWDER / INHALATION	RLD, RS	2012-12-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022549-001	ADASUVE	10MG	POWDER / INHALATION	RLD, RS	2012-12-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022549-001	ADASUVE	10MG	POWDER / INHALATION	RLD, RS	2012-12-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022549-001	ADASUVE	10MG	POWDER / INHALATION	RLD, RS	2012-12-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022549-001	ADASUVE	10MG	POWDER / INHALATION	RLD, RS	2012-12-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022549-001	ADASUVE	10MG	POWDER / INHALATION	RLD, RS	2012-12-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022549-001	ADASUVE	10MG	POWDER / INHALATION	RLD, RS	2012-12-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022549-001	ADASUVE	10MG	POWDER / INHALATION	RLD, RS	2012-12-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022549-001	ADASUVE	10MG	POWDER / INHALATION	RLD, RS	2012-12-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022549-001	ADASUVE	10MG	POWDER / INHALATION	RLD, RS	2012-12-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022549-001	ADASUVE	10MG	POWDER / INHALATION	RLD, RS	2012-12-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022549-001	ADASUVE	10MG	POWDER / INHALATION	RLD, RS	2012-12-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022549-001	ADASUVE	10MG	POWDER / INHALATION	RLD, RS	2012-12-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022549-001	ADASUVE	10MG	POWDER / INHALATION	RLD, RS	2012-12-21	`3a93d1ddd44b…`

Observed Orange Book patent history#

Patent history page 2 of 8 · 319 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022549-001	7458374	2024-08-18		Drug product	2013-03-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022549-001	7537009	2024-10-28		Drug product	2013-03-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022549-001	8387612	2026-10-23		Drug product	2013-03-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022549-001	9370629	2024-05-20		Drug product	2016-07-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022549-001	8991387	2024-05-21		Drug product	2015-04-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022549-001	7458374	2024-08-18		Drug product	2013-03-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022549-001	7537009	2024-10-28		Drug product	2013-03-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022549-001	8387612	2026-10-23		Drug product	2013-03-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022549-001	9370629	2024-05-20		Drug product	2016-07-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022549-001	8991387	2024-05-21		Drug product	2015-04-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022549-001	7458374	2024-08-18		Drug product	2013-03-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022549-001	7537009	2024-10-28		Drug product	2013-03-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022549-001	8387612	2026-10-23		Drug product	2013-03-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022549-001	6716416	2022-05-20		Drug product	2013-03-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022549-001	8074644	2022-07-25		Drug product	2013-03-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022549-001	9370629	2024-05-20		Drug product	2016-07-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022549-001	8991387	2024-05-21		Drug product	2015-04-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022549-001	7458374	2024-08-18		Drug product	2013-03-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022549-001	7537009	2024-10-28		Drug product	2013-03-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022549-001	8387612	2026-10-23		Drug product	2013-03-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022549-001	6716416	2022-05-20		Drug product	2013-03-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022549-001	8074644	2022-07-25		Drug product	2013-03-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022549-001	9370629	2024-05-20		Drug product	2016-07-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022549-001	8991387	2024-05-21		Drug product	2015-04-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022549-001	7458374	2024-08-18		Drug product	2013-03-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022549-001	7537009	2024-10-28		Drug product	2013-03-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022549-001	8387612	2026-10-23		Drug product	2013-03-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022549-001	6716416	2022-05-20		Drug product	2013-03-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022549-001	8074644	2022-07-25		Drug product	2013-03-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022549-001	9370629	2024-05-20		Drug product	2016-07-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022549-001	8991387	2024-05-21		Drug product	2015-04-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022549-001	7458374	2024-08-18		Drug product	2013-03-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022549-001	7537009	2024-10-28		Drug product	2013-03-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022549-001	8387612	2026-10-23		Drug product	2013-03-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022549-001	7052679	2021-10-26		Drug product	2013-03-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022549-001	7078020	2021-10-26	U-1375	Drug product	2013-03-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022549-001	7090830	2021-10-26		Drug product	2013-03-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022549-001	7585493	2021-10-26		Drug product	2013-03-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022549-001	7601337	2021-10-26		Drug product	2013-03-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022549-001	8173107	2021-10-26		Drug product	2013-03-29	`74a2ff9319b5…`

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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Loxapine	LOXAPINE	REMEDYREPACK INC.	ce8c5a31-7600-4525-a0c7-b3adc9ec2977	2026-09-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOXAPINE
Loxapine	LOXAPINE	REMEDYREPACK INC.	832ce6b1-5846-4a5b-adb4-ac4e0f502d78	2026-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOXAPINE
Loxapine	LOXAPINE	REMEDYREPACK INC.	ae8e299c-4003-4ccf-badc-fb665a997b20	2026-07-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOXAPINE
Loxapine	LOXAPINE	REMEDYREPACK INC.	2d45dd3c-71c3-4cc1-92ac-6dcecb195dd2	2026-07-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOXAPINE
Loxapine	LOXAPINE	REMEDYREPACK INC.	74ac619f-216b-4a79-b23a-158f4e44d25d	2026-07-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOXAPINE
Loxapine	LOXAPINE	REMEDYREPACK INC.	613a6459-0e61-4bed-9138-2836ff49f40b	2026-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOXAPINE
Loxapine	LOXAPINE	Chartwell RX, LLC	3e412c36-66b0-444b-833b-cea79976844e	2025-12-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOXAPINE
Loxapine	LOXAPINE	Actavis Pharma, Inc.	a6107bb1-3e23-4c5d-bbf4-5e29deff6728	2025-03-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOXAPINE
Loxapine	LOXAPINE	Elite Laboratories, Inc.	a0cc7bb6-075f-47d1-8935-eb77a29d8c45	2025-02-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOXAPINE
Loxapine	LOXAPINE	Coupler LLC	2cf83a3e-d76d-2a1f-e063-6294a90aa6bc	2025-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOXAPINE
Loxapine	LOXAPINE	Coupler LLC	2cf85ba7-7b62-6519-e063-6394a90a32c4	2025-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOXAPINE
Loxapine	LOXAPINE	Coupler LLC	2ce01a5d-b9bc-af4d-e063-6394a90af9e4	2025-01-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOXAPINE
Loxapine	LOXAPINE	Lannett Company, Inc.	509bad3c-b563-4042-b270-d28bde19f224	2024-11-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOXAPINE
Loxapine	LOXAPINE	Proficient Rx LP	3fa7b9c3-f500-49d5-b0c5-27ff01779713	2023-12-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOXAPINE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10885-003	Adasuve	loxapine	Galen US Incorporated	NDA	Current
10885-003	Adasuve	loxapine	Galen US Incorporated	NDA	Current
51097-001	Adasuve	loxapine	Alexza Pharmaceuticals, Inc.	NDA	Current
57844-510	Adasuve	loxapine	Teva Select Brands	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76422	ORIG	2023-11-06
70027	SUPPL	2022-02-01
70011	SUPPL	2022-01-31
69996	SUPPL	2022-01-31
69171	SUPPL	2021-10-29
69169	SUPPL	2021-10-29
69147	SUPPL	2021-10-28
56224	SUPPL	2018-11-01
47372	SUPPL	2017-03-02
47350	SUPPL	2017-02-27
47286	SUPPL	2017-02-22
45491	SUPPL	2016-09-30
7526	SUPPL	2013-12-13
53677	ORIG	2013-08-09
53676	ORIG	2013-08-09
53675	ORIG	2013-08-09
53673	ORIG	2013-01-11
53674	ORIG	2012-12-27