FDA.reportPublic FDA data

Application 022549

Type
NDA
Sponsor
ALEXZA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ADASUVELOXAPINEPOWDER;INHALATION10MGYesYes

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022549-001ADASUVELOXAPINE10MGPOWDER / INHALATIONRLD, RS2012-12-21

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N022549-00183876122026-10-23Drug product2013-03-29

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N022549-001ADASUVE10MGPOWDER / INHALATIONRLD, RS2012-12-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N022549-001ADASUVE10MGPOWDER / INHALATIONRLD, RS2012-12-21e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N022549-001ADASUVE10MGPOWDER / INHALATIONRLD, RS2012-12-21cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N022549-001ADASUVE10MGPOWDER / INHALATIONRLD, RS2012-12-21a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 8 · 319 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-10-15 13:18:302026-09N022549-00183876122026-10-23Drug product2013-03-29c2088c7a36db…
2026-09-14 22:38:342026-08N022549-00183876122026-10-23Drug product2013-03-2984e616aacf4f…
2026-08-18 06:07:402026-07N022549-00183876122026-10-23Drug product2013-03-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022549-00183876122026-10-23Drug product2013-03-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022549-00183876122026-10-23Drug product2013-03-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08N022549-00183876122026-10-23Drug product2013-03-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022549-00183876122026-10-23Drug product2013-03-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022549-00183876122026-10-23Drug product2013-03-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022549-00193706292024-05-20Drug product2016-07-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022549-00189913872024-05-21Drug product2015-04-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022549-00174583742024-08-18Drug product2013-03-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022549-00175370092024-10-28Drug product2013-03-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022549-00183876122026-10-23Drug product2013-03-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022549-00193706292024-05-20Drug product2016-07-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022549-00189913872024-05-21Drug product2015-04-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022549-00174583742024-08-18Drug product2013-03-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022549-00175370092024-10-28Drug product2013-03-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022549-00183876122026-10-23Drug product2013-03-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022549-00193706292024-05-20Drug product2016-07-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022549-00189913872024-05-21Drug product2015-04-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022549-00174583742024-08-18Drug product2013-03-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022549-00175370092024-10-28Drug product2013-03-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022549-00183876122026-10-23Drug product2013-03-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022549-00193706292024-05-20Drug product2016-07-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022549-00189913872024-05-21Drug product2015-04-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022549-00174583742024-08-18Drug product2013-03-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022549-00175370092024-10-28Drug product2013-03-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022549-00183876122026-10-23Drug product2013-03-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022549-00193706292024-05-20Drug product2016-07-07d06236e962d9…
2024-10-29 15:01 UTC2024-10N022549-00189913872024-05-21Drug product2015-04-29d06236e962d9…
2024-10-29 15:01 UTC2024-10N022549-00174583742024-08-18Drug product2013-03-29d06236e962d9…
2024-10-29 15:01 UTC2024-10N022549-00175370092024-10-28Drug product2013-03-29d06236e962d9…
2024-10-29 15:01 UTC2024-10N022549-00183876122026-10-23Drug product2013-03-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022549-00193706292024-05-20Drug product2016-07-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022549-00189913872024-05-21Drug product2015-04-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022549-00174583742024-08-18Drug product2013-03-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022549-00175370092024-10-28Drug product2013-03-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022549-00183876122026-10-23Drug product2013-03-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022549-00193706292024-05-20Drug product2016-07-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022549-00189913872024-05-21Drug product2015-04-29301d65b070ca…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LoxapineLOXAPINEREMEDYREPACK INC.ce8c5a31-7600-4525-a0c7-b3adc9ec29772026-09-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LOXAPINE
LoxapineLOXAPINEREMEDYREPACK INC.832ce6b1-5846-4a5b-adb4-ac4e0f502d782026-07-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LOXAPINE
LoxapineLOXAPINEREMEDYREPACK INC.ae8e299c-4003-4ccf-badc-fb665a997b202026-07-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LOXAPINE
LoxapineLOXAPINEREMEDYREPACK INC.2d45dd3c-71c3-4cc1-92ac-6dcecb195dd22026-07-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LOXAPINE
LoxapineLOXAPINEREMEDYREPACK INC.74ac619f-216b-4a79-b23a-158f4e44d25d2026-07-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LOXAPINE
LoxapineLOXAPINEREMEDYREPACK INC.613a6459-0e61-4bed-9138-2836ff49f40b2026-01-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LOXAPINE
LoxapineLOXAPINEChartwell RX, LLC3e412c36-66b0-444b-833b-cea79976844e2025-12-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LOXAPINE
LoxapineLOXAPINEActavis Pharma, Inc.a6107bb1-3e23-4c5d-bbf4-5e29deff67282025-03-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LOXAPINE
LoxapineLOXAPINEElite Laboratories, Inc.a0cc7bb6-075f-47d1-8935-eb77a29d8c452025-02-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LOXAPINE
LoxapineLOXAPINECoupler LLC2cf83a3e-d76d-2a1f-e063-6294a90aa6bc2025-01-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LOXAPINE
LoxapineLOXAPINECoupler LLC2cf85ba7-7b62-6519-e063-6394a90a32c42025-01-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LOXAPINE
LoxapineLOXAPINECoupler LLC2ce01a5d-b9bc-af4d-e063-6394a90af9e42025-01-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LOXAPINE
LoxapineLOXAPINELannett Company, Inc.509bad3c-b563-4042-b270-d28bde19f2242024-11-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LOXAPINE
LoxapineLOXAPINEProficient Rx LP3fa7b9c3-f500-49d5-b0c5-27ff017797132023-12-01Boxed warning, Warnings, Adverse reactionsName 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
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10885-003AdasuveloxapineGalen US IncorporatedNDACurrent
10885-003AdasuveloxapineGalen US IncorporatedNDACurrent
51097-001AdasuveloxapineAlexza Pharmaceuticals, Inc.NDACurrent
57844-510AdasuveloxapineTeva Select BrandsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76422ORIG 2023-11-06
70027SUPPL2022-02-01
70011SUPPL2022-01-31
69996SUPPL2022-01-31
69171SUPPL2021-10-29
69169SUPPL2021-10-29
69147SUPPL2021-10-28
56224SUPPL2018-11-01
47372SUPPL2017-03-02
47350SUPPL2017-02-27
47286SUPPL2017-02-22
45491SUPPL2016-09-30
7526SUPPL2013-12-13
53677ORIG2013-08-09
53676ORIG2013-08-09
53675ORIG2013-08-09
53673ORIG2013-01-11
53674ORIG2012-12-27