Home Applications 090423 Application 090423
Type ANDA
Sponsor SUN PHARM Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE SPRAY, METERED;NASAL EQ 0.125MG BASE/SPRAY No No
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090423-001 AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL 2012-05-23
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 · 42 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 2026-08-18 06:07:40 2026-07 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL 2012-05-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL 2012-05-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL 2012-05-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL 2012-05-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL 2012-05-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL 2012-05-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL 2012-05-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL 2012-05-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090423-001 AZELASTINE HYDROCHLORIDE EQ 0.125MG BASE/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090423-001 AZELASTINE HYDROCHLORIDE EQ 0.125MG BASE/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090423-001 AZELASTINE HYDROCHLORIDE EQ 0.125MG BASE/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090423-001 AZELASTINE HYDROCHLORIDE EQ 0.125MG BASE/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090423-001 AZELASTINE HYDROCHLORIDE EQ 0.125MG BASE/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090423-001 AZELASTINE HYDROCHLORIDE EQ 0.125MG BASE/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090423-001 AZELASTINE HYDROCHLORIDE EQ 0.125MG BASE/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090423-001 AZELASTINE HYDROCHLORIDE EQ 0.125MG BASE/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 e64feba35796…
Observed Orange Book normalized TE history# 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 2 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 47335-779 Azelastine Hydrochloride Azelastine Hydrochloride Sun Pharmaceutical Industries, Inc. ANDA Current 53002-2279 Azelastine Hydrochloride Azelastine Hydrochloride RPK Pharmaceuticals, Inc. ANDA Current