Home Applications 020114 Application 020114
Type NDA
Sponsor MYLAN SPECIALITY LP Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ASTELIN AZELASTINE HYDROCHLORIDE SPRAY, METERED;NASAL EQ 0.125MG BASE/SPRAY Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N020114-001 ASTELIN AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SPRAY, METERED / NASAL RLD 1996-11-01
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 1 of 2 · 43 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 2026-09-14 22:38:34 2026-08 N020114-001 ASTELIN 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SPRAY, METERED / NASAL RLD 1996-11-01 84e616aacf4f…2026-08-18 06:07:40 2026-07 N020114-001 ASTELIN 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SPRAY, METERED / NASAL RLD 1996-11-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020114-001 ASTELIN 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SPRAY, METERED / NASAL RLD 1996-11-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020114-001 ASTELIN 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SPRAY, METERED / NASAL RLD 1996-11-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020114-001 ASTELIN 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SPRAY, METERED / NASAL RLD 1996-11-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020114-001 ASTELIN 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SPRAY, METERED / NASAL RLD 1996-11-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020114-001 ASTELIN 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SPRAY, METERED / NASAL RLD 1996-11-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020114-001 ASTELIN 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SPRAY, METERED / NASAL RLD 1996-11-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020114-001 ASTELIN 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SPRAY, METERED / NASAL RLD 1996-11-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020114-001 ASTELIN 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SPRAY, METERED / NASAL RLD 1996-11-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020114-001 ASTELIN 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SPRAY, METERED / NASAL RLD 1996-11-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020114-001 ASTELIN 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SPRAY, METERED / NASAL RLD 1996-11-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020114-001 ASTELIN 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SPRAY, METERED / NASAL RLD 1996-11-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020114-001 ASTELIN 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SPRAY, METERED / NASAL RLD 1996-11-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020114-001 ASTELIN 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SPRAY, METERED / NASAL RLD 1996-11-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020114-001 ASTELIN 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SPRAY, METERED / NASAL RLD 1996-11-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020114-001 ASTELIN 0.137MG/SPRAY SPRAY, METERED / NASAL RLD 1996-11-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020114-001 ASTELIN 0.137MG/SPRAY SPRAY, METERED / NASAL RLD 1996-11-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020114-001 ASTELIN 0.137MG/SPRAY SPRAY, METERED / NASAL RLD 1996-11-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020114-001 ASTELIN EQ 0.125MG BASE/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1996-11-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020114-001 ASTELIN 0.137MG/SPRAY SPRAY, METERED / NASAL RLD 1996-11-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020114-001 ASTELIN 0.137MG/SPRAY SPRAY, METERED / NASAL RLD 1996-11-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020114-001 ASTELIN EQ 0.125MG BASE/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1996-11-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020114-001 ASTELIN EQ 0.125MG BASE/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1996-11-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020114-001 ASTELIN EQ 0.125MG BASE/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1996-11-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020114-001 ASTELIN EQ 0.125MG BASE/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1996-11-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020114-001 ASTELIN EQ 0.125MG BASE/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1996-11-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020114-001 ASTELIN EQ 0.125MG BASE/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1996-11-01 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020114-001 ASTELIN EQ 0.125MG BASE/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1996-11-01 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020114-001 ASTELIN 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SPRAY, METERED / NASAL RLD 1996-11-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020114-001 ASTELIN 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SPRAY, METERED / NASAL RLD 1996-11-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020114-001 ASTELIN 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SPRAY, METERED / NASAL RLD 1996-11-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020114-001 ASTELIN 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SPRAY, METERED / NASAL RLD 1996-11-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020114-001 ASTELIN 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SPRAY, METERED / NASAL RLD 1996-11-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020114-001 ASTELIN 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SPRAY, METERED / NASAL RLD 1996-11-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020114-001 ASTELIN 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SPRAY, METERED / NASAL RLD 1996-11-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020114-001 ASTELIN 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SPRAY, METERED / NASAL RLD 1996-11-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020114-001 ASTELIN 0.137MG/SPRAY SPRAY, METERED / NASAL RLD 1996-11-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020114-001 ASTELIN 0.137MG/SPRAY SPRAY, METERED / NASAL RLD 1996-11-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020114-001 ASTELIN 0.137MG/SPRAY SPRAY, METERED / NASAL RLD 1996-11-01 f41ea6bd6efb…
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 2 of 2 · 22 matching rows.
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 NDC Name Nonproprietary name Labeler Marketing category Status 0037-0241 Astelin azelastine hydrochloride Meda Pharmaceuticals NDA Current 50090-2538 Azelastine Hydrochloride Azelastine Hydrochloride A-S Medication Solutions NDA AUTHORIZED GENERIC Current 51525-0294 Azelastine Hydrochloride Azelastine Hydrochloride Wallace Pharmaceuticals Inc. NDA AUTHORIZED GENERIC Current 51525-0294 Azelastine Hydrochloride Azelastine Hydrochloride Wallace Pharmaceuticals Inc. NDA Current 51525-0294 Azelastine Hydrochloride Azelastine Hydrochloride Wallace Pharmaceuticals Inc. NDA AUTHORIZED GENERIC Current 51525-0294 Azelastine Hydrochloride Azelastine Hydrochloride Wallace Pharmaceuticals Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 57639 ORIG 2019-02-15 55433 SUPPL 2018-09-12 34270 SUPPL 2014-11-13 21169 SUPPL 2014-10-24 34269 SUPPL 2012-01-24 2026 SUPPL 2012-01-23 21168 SUPPL 2007-08-14 20475 SUPPL 2004-05-27 2025 SUPPL 2000-09-15 21167 SUPPL 2000-05-30