FDA.reportPublic FDA data

Application 020114

Type
NDA
Sponsor
MYLAN SPECIALITY LP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ASTELINAZELASTINE HYDROCHLORIDESPRAY, METERED;NASALEQ 0.125MG BASE/SPRAYYesYes

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
N020114-001ASTELINAZELASTINE HYDROCHLORIDE0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SPRAY, METERED / NASALRLD1996-11-01

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 UTC2022-10N020114-001ASTELIN0.137MG/SPRAYSPRAY, METERED / NASALRLD1996-11-01f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020114-001ASTELIN0.137MG/SPRAYSPRAY, METERED / NASALRLD1996-11-01e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020114-001ASTELIN0.137MG/SPRAYSPRAY, METERED / NASALRLD1996-11-01cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N020114-001ASTELIN0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SPRAY, METERED / NASALRLD1996-11-01a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12N020114-001AB174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020114-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N020114-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020114-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020114-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020114-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N020114-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N020114-001AB1ea99ee380514…

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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Azelastine HydrochlorideAZELASTINE HYDROCHLORIDEApotex Corp.4f58c203-f649-a18e-aaf3-70b0797652f42026-09-08Warnings, Adverse reactionsName fallback
generic name: AZELASTINE HYDROCHLORIDE
AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDEApotex Corp.77a33738-ffcf-221c-1562-780418882e5d2026-09-08Warnings, Adverse reactionsName fallback
generic name: AZELASTINE HYDROCHLORIDE
AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDEAurohealth LLC7281c597-651e-4425-8208-7637cd9d35002026-08-20WarningsName fallback
generic name: AZELASTINE HYDROCHLORIDE
AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDEYYBA Corp52f67910-11a7-6e7d-e063-6394a90ac9e82026-07-22WarningsName fallback
generic name: AZELASTINE HYDROCHLORIDE
Azelastine HydrochlorideAZELASTINE HYDROCHLORIDEWalgreensec268981-433f-b26b-4ff0-3a121e0a0d082026-04-16WarningsName fallback
generic name: AZELASTINE HYDROCHLORIDE
AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.37c40f8d-269c-4df8-8ac7-cbe78f4ca5c42026-03-11Warnings, Adverse reactionsName fallback
generic name: AZELASTINE HYDROCHLORIDE
Azelastine HydrochlorideAZELASTINE HYDROCHLORIDEFosun Pharma USA Inc8ae2aec7-329b-41bf-89d5-f189afb782ee2025-12-16Warnings, Adverse reactionsName fallback
generic name: AZELASTINE HYDROCHLORIDE
Azelastine HydrochlorideAZELASTINE HYDROCHLORIDESandoz Inc6945fb86-27fb-4bab-8908-98772c6269c52025-12-11Warnings, Adverse reactionsName fallback
generic name: AZELASTINE HYDROCHLORIDE
Azelastine HydrochlorideAZELASTINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.a2ba9c1d-b21f-4816-bbe6-949a49e385722025-11-17Warnings, Adverse reactionsName fallback
generic name: AZELASTINE HYDROCHLORIDE
Azelastine HydrochlorideAZELASTINE HYDROCHLORIDEA-S Medication Solutions02257284-4bb1-4fe6-8134-e5a67a6451142025-11-06Warnings, Adverse reactionsName fallback
generic name: AZELASTINE HYDROCHLORIDE
Azelastine HydrochlorideAZELASTINE HYDROCHLORIDEGland Pharma Limitedf358cecd-284f-4d0b-806c-039465220bd22025-10-22Warnings, Adverse reactionsName fallback
generic name: AZELASTINE HYDROCHLORIDE
Azelastine HydrochlorideAZELASTINE HYDROCHLORIDESomerset Therapeutics, LLC72406ded-7886-41fb-b5c8-2d27a149aa342025-09-26Warnings, Adverse reactionsName fallback
generic name: AZELASTINE HYDROCHLORIDE
AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDEAllegiant Healthcc7ddac6-95fa-4bc0-824d-f80e404e8d322025-05-02WarningsName fallback
generic name: AZELASTINE HYDROCHLORIDE
AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDEAllegiant Health3e2fdb0d-c2f5-41ab-b1cd-4fae806481122025-05-02WarningsName fallback
generic name: AZELASTINE HYDROCHLORIDE
AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDENorthStar Rx LLCcb0aca6d-ff9c-4239-8681-d212a6764ba92025-04-08Warnings, Adverse reactionsName fallback
generic name: AZELASTINE HYDROCHLORIDE
AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDEAlembic Pharmaceuticals Limited753d7a69-b0da-4350-9dc5-97f26ebe5cc02025-01-02Warnings, Adverse reactionsName fallback
generic name: AZELASTINE HYDROCHLORIDE
AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDEA-S Medication Solutionsfc9d031d-428d-4d53-8e63-feb96d5ab01a2024-11-20Warnings, Adverse reactionsName fallback
generic name: AZELASTINE HYDROCHLORIDE
AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDEAurobindo Pharma Limited97c91a09-98d0-4666-8448-0bd50c02bb142024-05-16Warnings, Adverse reactionsName fallback
generic name: AZELASTINE HYDROCHLORIDE
Azelastine HydrochlorideAZELASTINE HYDROCHLORIDEProficient Rx LP11a74cae-a15b-4a6b-a8c0-1e6a234ee2582023-10-01Warnings, Adverse reactionsName fallback
generic name: AZELASTINE HYDROCHLORIDE
Azelastine HydrochlorideAZELASTINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.305c6dc8-8247-473d-9975-b02903af6d532018-12-14Warnings, Adverse reactionsName fallback
generic name: AZELASTINE HYDROCHLORIDE

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0037-0241Astelinazelastine hydrochlorideMeda PharmaceuticalsNDACurrent
50090-2538Azelastine HydrochlorideAzelastine HydrochlorideA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
51525-0294Azelastine HydrochlorideAzelastine HydrochlorideWallace Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
51525-0294Azelastine HydrochlorideAzelastine HydrochlorideWallace Pharmaceuticals Inc.NDACurrent
51525-0294Azelastine HydrochlorideAzelastine HydrochlorideWallace Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
51525-0294Azelastine HydrochlorideAzelastine HydrochlorideWallace Pharmaceuticals Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
57639ORIG2019-02-15
55433SUPPL2018-09-12
34270SUPPL2014-11-13
21169SUPPL2014-10-24
34269SUPPL2012-01-24
2026SUPPL2012-01-23
21168SUPPL2007-08-14
20475SUPPL2004-05-27
2025SUPPL2000-09-15
21167SUPPL2000-05-30