Application 204660

Type: ANDA
Sponsor: AMNEAL PHARMS LLC

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
A204660-001	AZELASTINE HYDROCHLORIDE	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB		2017-08-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A204660-001	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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204660-001	AZELASTINE HYDROCHLORIDE	EQ 0.125MG BASE/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204660-001	AZELASTINE HYDROCHLORIDE	EQ 0.125MG BASE/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204660-001	AZELASTINE HYDROCHLORIDE	EQ 0.125MG BASE/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204660-001	AZELASTINE HYDROCHLORIDE	EQ 0.125MG BASE/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204660-001	AZELASTINE HYDROCHLORIDE	EQ 0.125MG BASE/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204660-001	AZELASTINE HYDROCHLORIDE	EQ 0.125MG BASE/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204660-001	AZELASTINE HYDROCHLORIDE	EQ 0.125MG BASE/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204660-001	AZELASTINE HYDROCHLORIDE	EQ 0.125MG BASE/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A204660-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204660-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204660-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204660-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204660-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204660-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204660-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204660-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204660-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204660-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204660-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204660-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204660-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204660-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204660-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204660-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204660-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204660-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204660-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204660-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204660-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204660-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204660-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204660-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204660-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204660-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204660-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204660-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204660-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204660-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204660-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204660-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204660-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204660-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204660-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204660-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204660-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204660-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204660-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204660-001	AB	1	`e64feba35796…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Azelastine Hydrochloride	AZELASTINE	AvKARE	bca75501-4140-4d77-e053-2a95a90a019f	2026-01-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204660 application number: ANDA204660 ndc (product): 42291-094
Azelastine Hydrochloride	AZELASTINE	Amneal Pharmaceuticals LLC	7902605c-944a-4d7e-a7d4-eb4a71bcacdb	2018-10-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204660 application number: ANDA204660 ndc (product): 65162-676

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42291-094	Azelastine Hydrochloride	Azelastine	AvKARE	ANDA	Current
42291-094	Azelastine Hydrochloride	Azelastine	AvKARE	ANDA	Current
50090-3833	Azelastine Hydrochloride	Azelastine	A-S Medication Solutions	ANDA	Current
50090-3833	Azelastine Hydrochloride	Azelastine	A-S Medication Solutions	ANDA	Current
50090-3833	Azelastine Hydrochloride	Azelastine	A-S Medication Solutions	ANDA	Current
65162-676	Azelastine Hydrochloride	Azelastine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-676	Azelastine Hydrochloride	Azelastine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-676	Azelastine Hydrochloride	Azelastine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-676	Azelastine Hydrochloride	Azelastine	Amneal Pharmaceuticals LLC	ANDA	Current