Home Applications 022549 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 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 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 · 41 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 2026-02-19 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…2022-10-28 04:53 UTC 2022-10 N022549-001 ADASUVE 10MG POWDER / INHALATION RLD, RS 2012-12-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022549-001 ADASUVE 10MG POWDER / INHALATION RLD, RS 2012-12-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022549-001 ADASUVE 10MG POWDER / INHALATION RLD, RS 2012-12-21 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 8 · 316 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 N022549-001 8387612 2026-10-23 Drug product 2013-03-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022549-001 8387612 2026-10-23 Drug product 2013-03-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022549-001 8387612 2026-10-23 Drug product 2013-03-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022549-001 8387612 2026-10-23 Drug product 2013-03-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022549-001 8387612 2026-10-23 Drug product 2013-03-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022549-001 9370629 2024-05-20 Drug product 2016-07-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022549-001 8991387 2024-05-21 Drug product 2015-04-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022549-001 7458374 2024-08-18 Drug product 2013-03-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022549-001 7537009 2024-10-28 Drug product 2013-03-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022549-001 8387612 2026-10-23 Drug product 2013-03-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022549-001 9370629 2024-05-20 Drug product 2016-07-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022549-001 8991387 2024-05-21 Drug product 2015-04-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022549-001 7458374 2024-08-18 Drug product 2013-03-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022549-001 7537009 2024-10-28 Drug product 2013-03-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022549-001 8387612 2026-10-23 Drug product 2013-03-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022549-001 9370629 2024-05-20 Drug product 2016-07-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022549-001 8991387 2024-05-21 Drug product 2015-04-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022549-001 7458374 2024-08-18 Drug product 2013-03-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022549-001 7537009 2024-10-28 Drug product 2013-03-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022549-001 8387612 2026-10-23 Drug product 2013-03-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022549-001 9370629 2024-05-20 Drug product 2016-07-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022549-001 8991387 2024-05-21 Drug product 2015-04-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022549-001 7458374 2024-08-18 Drug product 2013-03-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022549-001 7537009 2024-10-28 Drug product 2013-03-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022549-001 8387612 2026-10-23 Drug product 2013-03-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022549-001 9370629 2024-05-20 Drug product 2016-07-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022549-001 8991387 2024-05-21 Drug product 2015-04-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022549-001 7458374 2024-08-18 Drug product 2013-03-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022549-001 7537009 2024-10-28 Drug product 2013-03-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022549-001 8387612 2026-10-23 Drug product 2013-03-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022549-001 9370629 2024-05-20 Drug product 2016-07-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022549-001 8991387 2024-05-21 Drug product 2015-04-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022549-001 7458374 2024-08-18 Drug product 2013-03-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022549-001 7537009 2024-10-28 Drug product 2013-03-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022549-001 8387612 2026-10-23 Drug product 2013-03-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022549-001 9370629 2024-05-20 Drug product 2016-07-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022549-001 8991387 2024-05-21 Drug product 2015-04-29 301d65b070ca…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…
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 Adasuve LOXAPINE Alexza Pharmaceuticals, Inc. 50e11732-7387-452d-b3e6-db3a431d5c4a 2026-07-06 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 022549 application number: NDA022549 ndc (product): 51097-001
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