Application 201846

Type: ANDA
Sponsor: APOTEX INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AZELASTINE HYDROCHLORIDE	AZELASTINE HYDROCHLORIDE	SPRAY, METERED;NASAL	EQ 0.1876MG 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
A201846-001	AZELASTINE HYDROCHLORIDE	AZELASTINE HYDROCHLORIDE	0.2055MG/SPRAY	SPRAY, METERED / NASAL			2012-08-31

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	A201846-001	AZELASTINE HYDROCHLORIDE	0.2055MG/SPRAY	SPRAY, METERED / NASAL		2012-08-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201846-001	AZELASTINE HYDROCHLORIDE	0.2055MG/SPRAY	SPRAY, METERED / NASAL		2012-08-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201846-001	AZELASTINE HYDROCHLORIDE	0.2055MG/SPRAY	SPRAY, METERED / NASAL		2012-08-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201846-001	AZELASTINE HYDROCHLORIDE	0.2055MG/SPRAY	SPRAY, METERED / NASAL		2012-08-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201846-001	AZELASTINE HYDROCHLORIDE	0.2055MG/SPRAY	SPRAY, METERED / NASAL		2012-08-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201846-001	AZELASTINE HYDROCHLORIDE	0.2055MG/SPRAY	SPRAY, METERED / NASAL		2012-08-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201846-001	AZELASTINE HYDROCHLORIDE	0.2055MG/SPRAY	SPRAY, METERED / NASAL		2012-08-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201846-001	AZELASTINE HYDROCHLORIDE	0.2055MG/SPRAY	SPRAY, METERED / NASAL		2012-08-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201846-001	AZELASTINE HYDROCHLORIDE	0.2055MG/SPRAY	SPRAY, METERED / NASAL		2012-08-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201846-001	AZELASTINE HYDROCHLORIDE	0.2055MG/SPRAY	SPRAY, METERED / NASAL		2012-08-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201846-001	AZELASTINE HYDROCHLORIDE	0.2055MG/SPRAY	SPRAY, METERED / NASAL		2012-08-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201846-001	AZELASTINE HYDROCHLORIDE	0.2055MG/SPRAY	SPRAY, METERED / NASAL		2012-08-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201846-001	AZELASTINE HYDROCHLORIDE	0.2055MG/SPRAY	SPRAY, METERED / NASAL		2012-08-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201846-001	AZELASTINE HYDROCHLORIDE	0.2055MG/SPRAY	SPRAY, METERED / NASAL		2012-08-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201846-001	AZELASTINE HYDROCHLORIDE	0.2055MG/SPRAY	SPRAY, METERED / NASAL		2012-08-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201846-001	AZELASTINE HYDROCHLORIDE	0.2055MG/SPRAY	SPRAY, METERED / NASAL		2012-08-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201846-001	AZELASTINE HYDROCHLORIDE	0.2055MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-08-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201846-001	AZELASTINE HYDROCHLORIDE	0.2055MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-08-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201846-001	AZELASTINE HYDROCHLORIDE	EQ 0.1876MG BASE/SPRAY	SPRAY, METERED / NASAL	AB	2012-08-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201846-001	AZELASTINE HYDROCHLORIDE	0.2055MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-08-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201846-001	AZELASTINE HYDROCHLORIDE	0.2055MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-08-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201846-001	AZELASTINE HYDROCHLORIDE	EQ 0.1876MG BASE/SPRAY	SPRAY, METERED / NASAL	AB	2012-08-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201846-001	AZELASTINE HYDROCHLORIDE	EQ 0.1876MG BASE/SPRAY	SPRAY, METERED / NASAL	AB	2012-08-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201846-001	AZELASTINE HYDROCHLORIDE	EQ 0.1876MG BASE/SPRAY	SPRAY, METERED / NASAL	AB	2012-08-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201846-001	AZELASTINE HYDROCHLORIDE	EQ 0.1876MG BASE/SPRAY	SPRAY, METERED / NASAL	AB	2012-08-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201846-001	AZELASTINE HYDROCHLORIDE	EQ 0.1876MG BASE/SPRAY	SPRAY, METERED / NASAL	AB	2012-08-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201846-001	AZELASTINE HYDROCHLORIDE	EQ 0.1876MG BASE/SPRAY	SPRAY, METERED / NASAL	AB	2012-08-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201846-001	AZELASTINE HYDROCHLORIDE	EQ 0.1876MG BASE/SPRAY	SPRAY, METERED / NASAL	AB	2012-08-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201846-001	AZELASTINE HYDROCHLORIDE	0.2055MG/SPRAY	SPRAY, METERED / NASAL		2012-08-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201846-001	AZELASTINE HYDROCHLORIDE	0.2055MG/SPRAY	SPRAY, METERED / NASAL		2012-08-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201846-001	AZELASTINE HYDROCHLORIDE	0.2055MG/SPRAY	SPRAY, METERED / NASAL		2012-08-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201846-001	AZELASTINE HYDROCHLORIDE	0.2055MG/SPRAY	SPRAY, METERED / NASAL		2012-08-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201846-001	AZELASTINE HYDROCHLORIDE	0.2055MG/SPRAY	SPRAY, METERED / NASAL		2012-08-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201846-001	AZELASTINE HYDROCHLORIDE	0.2055MG/SPRAY	SPRAY, METERED / NASAL		2012-08-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201846-001	AZELASTINE HYDROCHLORIDE	0.2055MG/SPRAY	SPRAY, METERED / NASAL		2012-08-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201846-001	AZELASTINE HYDROCHLORIDE	0.2055MG/SPRAY	SPRAY, METERED / NASAL		2012-08-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201846-001	AZELASTINE HYDROCHLORIDE	0.2055MG/SPRAY	SPRAY, METERED / NASAL		2012-08-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201846-001	AZELASTINE HYDROCHLORIDE	0.2055MG/SPRAY	SPRAY, METERED / NASAL		2012-08-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201846-001	AZELASTINE HYDROCHLORIDE	0.2055MG/SPRAY	SPRAY, METERED / NASAL		2012-08-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201846-001	AZELASTINE HYDROCHLORIDE	0.2055MG/SPRAY	SPRAY, METERED / NASAL		2012-08-31	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-08 23:34 UTC	2022-04	A201846-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201846-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201846-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201846-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201846-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201846-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201846-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201846-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201846-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201846-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201846-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201846-001	AB	1	`ea99ee380514…`

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 · 24 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Azelastine Hydrochloride	AZELASTINE HYDROCHLORIDE	Sandoz Inc	6945fb86-27fb-4bab-8908-98772c6269c5	2021-08-26	Warnings, Adverse reactions	Name fallback brand name: Azelastine Hydrochloride generic name: AZELASTINE HYDROCHLORIDE
Azelastine Hydrochloride	AZELASTINE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	305c6dc8-8247-473d-9975-b02903af6d53	2018-12-14	Warnings, Adverse reactions	Name fallback brand name: Azelastine Hydrochloride generic name: AZELASTINE HYDROCHLORIDE
Azelastine Hydrochloride	AZELASTINE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	04e5eede-17ff-4765-af77-d46c139da703	2018-10-24	Warnings, Adverse reactions	Name fallback brand name: Azelastine Hydrochloride generic name: AZELASTINE HYDROCHLORIDE
Azelastine Hydrochloride	AZELASTINE	Amneal Pharmaceuticals LLC	7902605c-944a-4d7e-a7d4-eb4a71bcacdb	2018-10-18	Warnings, Adverse reactions	Name fallback brand name: Azelastine Hydrochloride

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
60505-0848	Azelastine Hydrochloride	Azelastine Hydrochloride	Apotex Corp.	ANDA	Current
60505-0848	Azelastine Hydrochloride	Azelastine Hydrochloride	Apotex Corp.	ANDA	Current
60505-0848	Azelastine Hydrochloride	Azelastine Hydrochloride	Apotex Corp.	ANDA	Current
60505-0848	Azelastine Hydrochloride	Azelastine Hydrochloride	Apotex Corp.	ANDA	Current
68071-2498	Azelastine Hydrochloride	Azelastine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
43375	ORIG	2012-10-09