Home Applications 022203 Application 022203
Type NDA
Sponsor MYLAN SPECIALITY LP Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ASTEPRO AZELASTINE HYDROCHLORIDE SPRAY, METERED;NASAL EQ 0.125MG BASE/SPRAY No No 002 ASTEPRO AZELASTINE HYDROCHLORIDE SPRAY, METERED;NASAL EQ 0.1876MG 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022203-001 ASTEPRO AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SPRAY, METERED / NASAL RLD 2008-10-15 N022203-002 ASTEPRO AZELASTINE HYDROCHLORIDE 0.2055MG/SPRAY SPRAY, METERED / NASAL 2009-08-31
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022203-001 8071073 2028-06-04 Drug product 2011-12-15 N022203-002 8071073 2028-06-04 Drug product 2011-12-15
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 3 · 86 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 N022203-001 ASTEPRO 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SPRAY, METERED / NASAL RLD 2008-10-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022203-002 ASTEPRO 0.2055MG/SPRAY SPRAY, METERED / NASAL 2009-08-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022203-001 ASTEPRO 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SPRAY, METERED / NASAL RLD 2008-10-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022203-002 ASTEPRO 0.2055MG/SPRAY SPRAY, METERED / NASAL 2009-08-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022203-001 ASTEPRO 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SPRAY, METERED / NASAL RLD 2008-10-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022203-002 ASTEPRO 0.2055MG/SPRAY SPRAY, METERED / NASAL 2009-08-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022203-001 ASTEPRO 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SPRAY, METERED / NASAL RLD 2008-10-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022203-002 ASTEPRO 0.2055MG/SPRAY SPRAY, METERED / NASAL 2009-08-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022203-001 ASTEPRO 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SPRAY, METERED / NASAL RLD 2008-10-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022203-002 ASTEPRO 0.2055MG/SPRAY SPRAY, METERED / NASAL 2009-08-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022203-001 ASTEPRO 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SPRAY, METERED / NASAL RLD 2008-10-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022203-002 ASTEPRO 0.2055MG/SPRAY SPRAY, METERED / NASAL 2009-08-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022203-001 ASTEPRO 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SPRAY, METERED / NASAL RLD 2008-10-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022203-002 ASTEPRO 0.2055MG/SPRAY SPRAY, METERED / NASAL 2009-08-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022203-001 ASTEPRO 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SPRAY, METERED / NASAL RLD 2008-10-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022203-002 ASTEPRO 0.2055MG/SPRAY SPRAY, METERED / NASAL 2009-08-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022203-001 ASTEPRO 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SPRAY, METERED / NASAL RLD 2008-10-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022203-002 ASTEPRO 0.2055MG/SPRAY SPRAY, METERED / NASAL 2009-08-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022203-001 ASTEPRO 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SPRAY, METERED / NASAL RLD 2008-10-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022203-002 ASTEPRO 0.2055MG/SPRAY SPRAY, METERED / NASAL 2009-08-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022203-001 ASTEPRO 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SPRAY, METERED / NASAL RLD 2008-10-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022203-002 ASTEPRO 0.2055MG/SPRAY SPRAY, METERED / NASAL 2009-08-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022203-001 ASTEPRO 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SPRAY, METERED / NASAL RLD 2008-10-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022203-002 ASTEPRO 0.2055MG/SPRAY SPRAY, METERED / NASAL 2009-08-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022203-001 ASTEPRO 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SPRAY, METERED / NASAL RLD 2008-10-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022203-002 ASTEPRO 0.2055MG/SPRAY SPRAY, METERED / NASAL 2009-08-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022203-001 ASTEPRO 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SPRAY, METERED / NASAL RLD 2008-10-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022203-002 ASTEPRO 0.2055MG/SPRAY SPRAY, METERED / NASAL 2009-08-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022203-001 ASTEPRO 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SPRAY, METERED / NASAL RLD 2008-10-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022203-002 ASTEPRO 0.2055MG/SPRAY SPRAY, METERED / NASAL 2009-08-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022203-001 ASTEPRO 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SPRAY, METERED / NASAL RLD 2008-10-15 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N022203-002 ASTEPRO 0.2055MG/SPRAY SPRAY, METERED / NASAL 2009-08-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022203-001 ASTEPRO 0.137MG/SPRAY SPRAY, METERED / NASAL RLD 2008-10-15 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022203-002 ASTEPRO 0.2055MG/SPRAY SPRAY, METERED / NASAL 2009-08-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022203-001 ASTEPRO 0.137MG/SPRAY SPRAY, METERED / NASAL RLD 2008-10-15 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022203-002 ASTEPRO 0.2055MG/SPRAY SPRAY, METERED / NASAL 2009-08-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022203-001 ASTEPRO 0.137MG/SPRAY SPRAY, METERED / NASAL RLD 2008-10-15 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022203-002 ASTEPRO 0.2055MG/SPRAY SPRAY, METERED / NASAL 2009-08-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022203-001 ASTEPRO EQ 0.125MG BASE/SPRAY SPRAY, METERED / NASAL 2008-10-15 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022203-002 ASTEPRO EQ 0.1876MG BASE/SPRAY SPRAY, METERED / NASAL AB RLD, RS 2009-08-31 74a2ff9319b5…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 6 · 203 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N022203-001 8071073 2028-06-04 Drug product 2011-12-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022203-002 8071073 2028-06-04 Drug product 2011-12-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022203-001 8071073 2028-06-04 Drug product 2011-12-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022203-002 8071073 2028-06-04 Drug product 2011-12-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022203-001 8071073 2028-06-04 Drug product 2011-12-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022203-002 8071073 2028-06-04 Drug product 2011-12-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022203-001 8518919 2025-11-22 U-1430 2013-09-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022203-001 8071073 2028-06-04 Drug product 2011-12-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022203-002 8518919 2025-11-22 U-1430 2013-09-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022203-002 9919050 2025-11-22 Drug product 2018-03-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022203-002 8071073 2028-06-04 Drug product 2011-12-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022203-001 8518919 2025-11-22 U-1430 2013-09-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022203-001 8071073 2028-06-04 Drug product 2011-12-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022203-002 8518919 2025-11-22 U-1430 2013-09-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022203-002 9919050 2025-11-22 Drug product 2018-03-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022203-002 8071073 2028-06-04 Drug product 2011-12-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022203-001 8518919 2025-11-22 U-1430 2013-09-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022203-001 8071073 2028-06-04 Drug product 2011-12-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022203-002 8518919 2025-11-22 U-1430 2013-09-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022203-002 9919050 2025-11-22 Drug product 2018-03-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022203-002 8071073 2028-06-04 Drug product 2011-12-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022203-001 8518919 2025-11-22 U-1430 2013-09-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022203-001 8071073 2028-06-04 Drug product 2011-12-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022203-002 8518919 2025-11-22 U-1430 2013-09-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022203-002 9919050 2025-11-22 Drug product 2018-03-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022203-002 8071073 2028-06-04 Drug product 2011-12-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022203-001 8518919 2025-11-22 U-1430 2013-09-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022203-001 8071073 2028-06-04 Drug product 2011-12-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022203-002 8518919 2025-11-22 U-1430 2013-09-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022203-002 9919050 2025-11-22 Drug product 2018-03-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022203-002 8071073 2028-06-04 Drug product 2011-12-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022203-001 8518919 2025-11-22 U-1430 2013-09-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022203-001 8071073 2028-06-04 Drug product 2011-12-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022203-002 8518919 2025-11-22 U-1430 2013-09-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022203-002 9919050 2025-11-22 Drug product 2018-03-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022203-002 8071073 2028-06-04 Drug product 2011-12-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022203-001 8518919 2025-11-22 U-1430 2013-09-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022203-001 8071073 2028-06-04 Drug product 2011-12-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022203-002 8518919 2025-11-22 U-1430 2013-09-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022203-002 9919050 2025-11-22 Drug product 2018-03-29 5bbf6a4d5a75…
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 0037-0242 Astepro Azelastine Hydrochloride Meda Pharmaceuticals NDA Current 0037-0243 Astepro Azelastine Hydrochloride Meda Pharmaceuticals NDA Current 0037-0243 Astepro Azelastine Hydrochloride Meda Pharmaceuticals NDA Current 51525-0234 AZELASTINE HYDROCHLORIDE azelastine hydrochloride Wallace Pharmaceuticals Inc. NDA AUTHORIZED GENERIC Current 51525-0234 Azelastine Hydrochloride azelastine hydrochloride Wallace Pharmaceuticals Inc. NDA AUTHORIZED GENERIC Current 51525-0234 Azelastine Hydrochloride azelastine hydrochloride Wallace Pharmaceuticals Inc. NDA AUTHORIZED GENERIC Current