Home Applications 207610 Application 207610
Type ANDA
Sponsor HI TECH 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 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 A207610-001 AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2019-05-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A207610-001 AB
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 A207610-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2019-05-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207610-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2019-05-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207610-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2019-05-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207610-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2019-05-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207610-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2019-05-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207610-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2019-05-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207610-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2019-05-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207610-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2019-05-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207610-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2019-05-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207610-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2019-05-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207610-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2019-05-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207610-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2019-05-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207610-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2019-05-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207610-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2019-05-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207610-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2019-05-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207610-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2019-05-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207610-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2019-05-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207610-001 AZELASTINE HYDROCHLORIDE EQ 0.125MG BASE/SPRAY SPRAY, METERED / NASAL AB 2019-05-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207610-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2019-05-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207610-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2019-05-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207610-001 AZELASTINE HYDROCHLORIDE EQ 0.125MG BASE/SPRAY SPRAY, METERED / NASAL AB 2019-05-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207610-001 AZELASTINE HYDROCHLORIDE EQ 0.125MG BASE/SPRAY SPRAY, METERED / NASAL AB 2019-05-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A207610-001 AZELASTINE HYDROCHLORIDE EQ 0.125MG BASE/SPRAY SPRAY, METERED / NASAL AB 2019-05-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A207610-001 AZELASTINE HYDROCHLORIDE EQ 0.125MG BASE/SPRAY SPRAY, METERED / NASAL AB 2019-05-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A207610-001 AZELASTINE HYDROCHLORIDE EQ 0.125MG BASE/SPRAY SPRAY, METERED / NASAL AB 2019-05-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A207610-001 AZELASTINE HYDROCHLORIDE EQ 0.125MG BASE/SPRAY SPRAY, METERED / NASAL AB 2019-05-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A207610-001 AZELASTINE HYDROCHLORIDE EQ 0.125MG BASE/SPRAY SPRAY, METERED / NASAL AB 2019-05-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207610-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2019-05-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207610-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2019-05-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207610-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2019-05-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207610-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2019-05-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207610-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2019-05-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207610-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2019-05-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207610-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2019-05-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207610-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2019-05-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207610-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2019-05-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207610-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2019-05-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A207610-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2019-05-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A207610-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2019-05-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A207610-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2019-05-17 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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 · 24 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE YYBA Corp 52f67910-11a7-6e7d-e063-6394a90ac9e8 2026-07-22 Warnings Name fallback brand name: AZELASTINE HYDROCHLORIDE generic name: AZELASTINE HYDROCHLORIDE Azelastine Hydrochloride AZELASTINE HYDROCHLORIDE CVS PHARMACY, INC 22d516d0-da22-4e3b-a4a5-135b009bc968 2026-05-21 Warnings Name fallback brand name: Azelastine Hydrochloride generic name: AZELASTINE HYDROCHLORIDE Azelastine Hydrochloride AZELASTINE HYDROCHLORIDE Walgreens ec268981-433f-b26b-4ff0-3a121e0a0d08 2026-04-16 Warnings Name fallback brand name: Azelastine Hydrochloride generic name: AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE Preferred Pharmaceuticals Inc. 37c40f8d-269c-4df8-8ac7-cbe78f4ca5c4 2026-03-11 Warnings, Adverse reactions Name fallback brand name: AZELASTINE HYDROCHLORIDE generic name: AZELASTINE HYDROCHLORIDE Azelastine Hydrochloride AZELASTINE AvKARE bca75501-4140-4d77-e053-2a95a90a019f 2026-01-14 Warnings, Adverse reactions Name fallback brand name: Azelastine Hydrochloride Azelastine Hydrochloride AZELASTINE HYDROCHLORIDE Fosun Pharma USA Inc 8ae2aec7-329b-41bf-89d5-f189afb782ee 2025-12-16 Warnings, Adverse reactions Name fallback brand name: Azelastine Hydrochloride generic name: AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE Aurohealth LLC 7281c597-651e-4425-8208-7637cd9d3500 2025-12-15 Warnings Name fallback brand name: AZELASTINE HYDROCHLORIDE generic name: AZELASTINE HYDROCHLORIDE Azelastine Hydrochloride AZELASTINE HYDROCHLORIDE Preferred Pharmaceuticals Inc. a2ba9c1d-b21f-4816-bbe6-949a49e38572 2025-11-17 Warnings, Adverse reactions Name fallback brand name: Azelastine Hydrochloride generic name: AZELASTINE HYDROCHLORIDE Azelastine Hydrochloride AZELASTINE HYDROCHLORIDE A-S Medication Solutions 02257284-4bb1-4fe6-8134-e5a67a645114 2025-11-06 Warnings, Adverse reactions Name fallback brand name: Azelastine Hydrochloride generic name: AZELASTINE HYDROCHLORIDE Azelastine Hydrochloride AZELASTINE HYDROCHLORIDE Gland Pharma Limited f358cecd-284f-4d0b-806c-039465220bd2 2025-10-22 Warnings, Adverse reactions Name fallback brand name: Azelastine Hydrochloride generic name: AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE Apotex Corp. 77a33738-ffcf-221c-1562-780418882e5d 2025-10-06 Warnings, Adverse reactions Name fallback brand name: AZELASTINE HYDROCHLORIDE generic name: AZELASTINE HYDROCHLORIDE Azelastine Hydrochloride AZELASTINE HYDROCHLORIDE Somerset Therapeutics, LLC 72406ded-7886-41fb-b5c8-2d27a149aa34 2025-09-26 Warnings, Adverse reactions Name fallback brand name: Azelastine Hydrochloride generic name: AZELASTINE HYDROCHLORIDE Azelastine Hydrochloride AZELASTINE HYDROCHLORIDE Apotex Corp. 4f58c203-f649-a18e-aaf3-70b0797652f4 2025-09-16 Warnings, Adverse reactions Name fallback brand name: Azelastine Hydrochloride generic name: AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE Allegiant Health cc7ddac6-95fa-4bc0-824d-f80e404e8d32 2025-05-02 Warnings Name fallback brand name: AZELASTINE HYDROCHLORIDE generic name: AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE Allegiant Health 3e2fdb0d-c2f5-41ab-b1cd-4fae80648112 2025-05-02 Warnings Name fallback brand name: AZELASTINE HYDROCHLORIDE generic name: AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE NorthStar Rx LLC cb0aca6d-ff9c-4239-8681-d212a6764ba9 2025-04-08 Warnings, Adverse reactions Name fallback brand name: AZELASTINE HYDROCHLORIDE generic name: AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE Alembic Pharmaceuticals Limited 753d7a69-b0da-4350-9dc5-97f26ebe5cc0 2025-01-02 Warnings, Adverse reactions Name fallback brand name: AZELASTINE HYDROCHLORIDE generic name: AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE A-S Medication Solutions fc9d031d-428d-4d53-8e63-feb96d5ab01a 2024-11-20 Warnings, Adverse reactions Name fallback brand name: AZELASTINE HYDROCHLORIDE generic name: AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE Aurobindo Pharma Limited 97c91a09-98d0-4666-8448-0bd50c02bb14 2024-05-16 Warnings, Adverse reactions Name fallback brand name: AZELASTINE HYDROCHLORIDE generic name: AZELASTINE HYDROCHLORIDE Azelastine Hydrochloride AZELASTINE HYDROCHLORIDE Proficient Rx LP 11a74cae-a15b-4a6b-a8c0-1e6a234ee258 2023-10-01 Warnings, Adverse reactions Name fallback brand name: Azelastine Hydrochloride generic name: AZELASTINE HYDROCHLORIDE
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 50383-738 Azelastine Hydrochloride Azelastine Hydrochloride Hi-Tech Pharmacal Co., Inc. ANDA Current 50383-738 Azelastine Hydrochloride Azelastine Hydrochloride Akorn ANDA Current 50383-738 Azelastine Hydrochloride Azelastine Hydrochloride Hi-Tech Pharmacal Co., Inc. ANDA Current