FDA.reportPublic FDA data

Application 216576

Type
ANDA
Sponsor
AMNEAL PHARMS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDESPRAY;NASAL205.5MCGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A216576-001AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDE0.2055MG/SPRAYSPRAY, METERED / NASAL2024-06-05

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A216576-001AZELASTINE HYDROCHLORIDE0.2055MG/SPRAYSPRAY, METERED / NASAL2024-06-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A216576-001AZELASTINE HYDROCHLORIDE0.2055MG/SPRAYSPRAY, METERED / NASAL2024-06-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216576-001AZELASTINE HYDROCHLORIDE0.2055MG/SPRAYSPRAY, METERED / NASAL2024-06-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A216576-001AZELASTINE HYDROCHLORIDE0.2055MG/SPRAYSPRAY, METERED / NASAL2024-06-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216576-001AZELASTINE HYDROCHLORIDE0.2055MG/SPRAYSPRAY, METERED / NASAL2024-06-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216576-001AZELASTINE HYDROCHLORIDE0.2055MG/SPRAYSPRAY, METERED / NASAL2024-06-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216576-001AZELASTINE HYDROCHLORIDE0.2055MG/SPRAYSPRAY, METERED / NASAL2024-06-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216576-001AZELASTINE HYDROCHLORIDE0.2055MG/SPRAYSPRAY, METERED / NASAL2024-06-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216576-001AZELASTINE HYDROCHLORIDE0.2055MG/SPRAYSPRAY, METERED / NASAL2024-06-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216576-001AZELASTINE HYDROCHLORIDE0.2055MG/SPRAYSPRAY, METERED / NASAL2024-06-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216576-001AZELASTINE HYDROCHLORIDE0.2055MG/SPRAYSPRAY, METERED / NASAL2024-06-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216576-001AZELASTINE HYDROCHLORIDE0.2055MG/SPRAYSPRAY, METERED / NASAL2024-06-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216576-001AZELASTINE HYDROCHLORIDE0.2055MG/SPRAYSPRAY, METERED / NASAL2024-06-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216576-001AZELASTINE HYDROCHLORIDE0.2055MG/SPRAYSPRAY, METERED / NASAL2024-06-051e350fbaab3a…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216576-001AZELASTINE HYDROCHLORIDE0.2055MG/SPRAYSPRAY, METERED / NASAL2024-06-05a50c72e98297…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Azelastine HClAZELASTINEAmneal Pharmaceuticals NY LLC82610437-25f4-4ae0-9d6a-381e9932f87d2025-11-03WarningsExact identifier
application applno (ANDA): 216576
application number: ANDA216576