Application 209620

Type: ANDA
Sponsor: ALEMBIC PHARMS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AZELASTINE HYDROCHLORIDE	AZELASTINE HYDROCHLORIDE	SOLUTION/DROPS;OPHTHALMIC	0.05%	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
A209620-001	AZELASTINE HYDROCHLORIDE	AZELASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	AT		2019-03-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209620-001	AT

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	A209620-001	AZELASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-03-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209620-001	AZELASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-03-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209620-001	AZELASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-03-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209620-001	AZELASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-03-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209620-001	AZELASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-03-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209620-001	AZELASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-03-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209620-001	AZELASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-03-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209620-001	AZELASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-03-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209620-001	AZELASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-03-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209620-001	AZELASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-03-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209620-001	AZELASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-03-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209620-001	AZELASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-03-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209620-001	AZELASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-03-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209620-001	AZELASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-03-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209620-001	AZELASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-03-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209620-001	AZELASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-03-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209620-001	AZELASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-03-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209620-001	AZELASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-03-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209620-001	AZELASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-03-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209620-001	AZELASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-03-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209620-001	AZELASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-03-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209620-001	AZELASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-03-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209620-001	AZELASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-03-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209620-001	AZELASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-03-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209620-001	AZELASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-03-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209620-001	AZELASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-03-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209620-001	AZELASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-03-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209620-001	AZELASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-03-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209620-001	AZELASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-03-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209620-001	AZELASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-03-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209620-001	AZELASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-03-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209620-001	AZELASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-03-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209620-001	AZELASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-03-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209620-001	AZELASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-03-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209620-001	AZELASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-03-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209620-001	AZELASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-03-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209620-001	AZELASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-03-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209620-001	AZELASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-03-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209620-001	AZELASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-03-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209620-001	AZELASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-03-20	`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	A209620-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209620-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209620-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209620-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209620-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209620-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209620-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209620-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209620-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209620-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209620-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209620-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209620-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209620-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209620-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209620-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209620-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209620-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209620-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209620-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209620-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209620-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209620-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209620-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209620-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209620-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209620-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209620-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209620-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209620-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209620-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209620-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209620-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209620-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209620-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209620-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209620-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209620-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209620-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209620-001	AT	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 Ophthalmic Solution 0.05%	AZELASTINE HYDROCHLORIDE OPHTHALMIC SOLUTION 0.05%	Alembic Pharmaceuticals Inc.	7532ed82-5cfa-49da-83e5-c57ffdd3adbb	2025-01-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209620 application number: ANDA209620 ndc (product): 62332-506
AZELASTINE HYDROCHLORIDE	AZELASTINE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	753d7a69-b0da-4350-9dc5-97f26ebe5cc0	2025-01-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209620 application number: ANDA209620

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
62332-506	Azelastine Hydrochloride Ophthalmic Solution 0.05%	Azelastine Hydrochloride Ophthalmic Solution 0.05%	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-506	Azelastine Hydrochloride Ophthalmic Solution 0.05%	Azelastine Hydrochloride Ophthalmic Solution 0.05%	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-506	Azelastine Hydrochloride Ophthalmic Solution 0.05%	Azelastine Hydrochloride Ophthalmic Solution 0.05%	Alembic Pharmaceuticals Inc.	ANDA	Current