Application 207243

Type: ANDA
Sponsor: HIKMA

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 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
A207243-001	AZELASTINE HYDROCHLORIDE	AZELASTINE HYDROCHLORIDE	0.2055MG/SPRAY	SPRAY, METERED / NASAL			2017-09-22

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 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2022-09-29 23:25 UTC	2022-09	A207243-001	AZELASTINE HYDROCHLORIDE	0.2055MG/SPRAY	SPRAY, METERED / NASAL	2017-09-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207243-001	AZELASTINE HYDROCHLORIDE	0.2055MG/SPRAY	SPRAY, METERED / NASAL	2017-09-22	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A207243-001	AZELASTINE HYDROCHLORIDE	0.2055MG/SPRAY	SPRAY, METERED / NASAL	2017-09-22	`a50c72e98297…`

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	A207243-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207243-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207243-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207243-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207243-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207243-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207243-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207243-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207243-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207243-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207243-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207243-001	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 1 of 2 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Azelastine Hydrochloride	AZELASTINE HYDROCHLORIDE	Apotex Corp.	4f58c203-f649-a18e-aaf3-70b0797652f4	2026-09-08	Warnings, Adverse reactions	Name fallback brand name: Azelastine Hydrochloride generic name: AZELASTINE HYDROCHLORIDE
AZELASTINE HYDROCHLORIDE	AZELASTINE HYDROCHLORIDE	Apotex Corp.	77a33738-ffcf-221c-1562-780418882e5d	2026-09-08	Warnings, Adverse reactions	Name fallback brand name: AZELASTINE HYDROCHLORIDE generic name: AZELASTINE HYDROCHLORIDE
AZELASTINE HYDROCHLORIDE	AZELASTINE HYDROCHLORIDE	Aurohealth LLC	7281c597-651e-4425-8208-7637cd9d3500	2026-08-20	Warnings	Name fallback brand name: AZELASTINE HYDROCHLORIDE generic name: AZELASTINE HYDROCHLORIDE
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	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	Sandoz Inc	6945fb86-27fb-4bab-8908-98772c6269c5	2025-12-11	Warnings, Adverse reactions	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	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	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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.