Application 021565

Type: NDA
Sponsor: ALLERGAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ELESTAT	EPINASTINE HYDROCHLORIDE	SOLUTION/DROPS;OPHTHALMIC	0.05%	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N021565-001	ELESTAT	EPINASTINE HYDROCHLORIDE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	2003-10-16

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 · 41 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
2026-02-19 14:30 UTC	2026-02	N021565-001	ELESTAT	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	2003-10-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021565-001	ELESTAT	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	2003-10-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021565-001	ELESTAT	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	2003-10-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021565-001	ELESTAT	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	2003-10-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021565-001	ELESTAT	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	2003-10-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021565-001	ELESTAT	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	2003-10-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021565-001	ELESTAT	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	2003-10-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021565-001	ELESTAT	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	2003-10-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021565-001	ELESTAT	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	2003-10-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021565-001	ELESTAT	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	2003-10-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021565-001	ELESTAT	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	2003-10-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021565-001	ELESTAT	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	2003-10-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021565-001	ELESTAT	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	2003-10-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021565-001	ELESTAT	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	2003-10-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021565-001	ELESTAT	0.05%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-10-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021565-001	ELESTAT	0.05%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-10-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021565-001	ELESTAT	0.05%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-10-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021565-001	ELESTAT	0.05%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-10-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021565-001	ELESTAT	0.05%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-10-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021565-001	ELESTAT	0.05%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-10-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021565-001	ELESTAT	0.05%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-10-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021565-001	ELESTAT	0.05%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-10-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021565-001	ELESTAT	0.05%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-10-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021565-001	ELESTAT	0.05%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-10-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021565-001	ELESTAT	0.05%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-10-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021565-001	ELESTAT	0.05%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-10-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021565-001	ELESTAT	0.05%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-10-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021565-001	ELESTAT	0.05%	SOLUTION/DROPS / OPHTHALMIC		RLD	2003-10-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021565-001	ELESTAT	0.05%	SOLUTION/DROPS / OPHTHALMIC		RLD	2003-10-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021565-001	ELESTAT	0.05%	SOLUTION/DROPS / OPHTHALMIC		RLD	2003-10-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021565-001	ELESTAT	0.05%	SOLUTION/DROPS / OPHTHALMIC		RLD	2003-10-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021565-001	ELESTAT	0.05%	SOLUTION/DROPS / OPHTHALMIC		RLD	2003-10-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021565-001	ELESTAT	0.05%	SOLUTION/DROPS / OPHTHALMIC		RLD	2003-10-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021565-001	ELESTAT	0.05%	SOLUTION/DROPS / OPHTHALMIC		RLD	2003-10-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021565-001	ELESTAT	0.05%	SOLUTION/DROPS / OPHTHALMIC		RLD	2003-10-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021565-001	ELESTAT	0.05%	SOLUTION/DROPS / OPHTHALMIC		RLD	2003-10-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021565-001	ELESTAT	0.05%	SOLUTION/DROPS / OPHTHALMIC		RLD	2003-10-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021565-001	ELESTAT	0.05%	SOLUTION/DROPS / OPHTHALMIC		RLD	2003-10-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021565-001	ELESTAT	0.05%	SOLUTION/DROPS / OPHTHALMIC		RLD	2003-10-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021565-001	ELESTAT	0.05%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-10-16	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021565-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021565-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021565-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021565-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021565-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021565-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021565-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021565-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021565-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021565-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021565-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021565-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021565-001	AT	1	`ea99ee380514…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021565-001	AT	1	`cb3db0bc1861…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EPINASTINE HYDROCHLORIDE	EPINASTINE HYDROCHLORIDE	Somerset Therapeutics, LLC	0d4ee45c-e58f-4b7c-b389-898f5c27f54d	2025-03-22	Warnings, Adverse reactions	Name fallback generic name: EPINASTINE HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0023-9201	ELESTAT	epinastine hydrochloride	Allergan, Inc.	NDA	Current
0023-9201	ELESTAT	epinastine hydrochloride	Allergan, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
15781	SUPPL	2011-12-23
28120	SUPPL	2011-12-22
28119	SUPPL	2005-08-19
37228	SUPPL	2005-08-16
42211	ORIG	2003-12-31
15780	ORIG	2003-10-17
5740	ORIG	2003-10-14