Application 203384

Type: ANDA
Sponsor: CHARTWELL RX

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EPINASTINE HYDROCHLORIDE	EPINASTINE HYDROCHLORIDE	SOLUTION/DROPS;OPHTHALMIC	0.05%	No	No

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
A203384-001	EPINASTINE HYDROCHLORIDE	EPINASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC			2016-12-07

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203384-001	EPINASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	2016-12-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203384-001	EPINASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	2016-12-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203384-001	EPINASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	2016-12-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203384-001	EPINASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	2016-12-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203384-001	EPINASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	2016-12-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203384-001	EPINASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	2016-12-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203384-001	EPINASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	2016-12-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203384-001	EPINASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	2016-12-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203384-001	EPINASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	2016-12-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203384-001	EPINASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	2016-12-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203384-001	EPINASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	2016-12-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203384-001	EPINASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	2016-12-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203384-001	EPINASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	2016-12-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203384-001	EPINASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	2016-12-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203384-001	EPINASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	2016-12-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203384-001	EPINASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	2016-12-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203384-001	EPINASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	2016-12-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203384-001	EPINASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	2016-12-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203384-001	EPINASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	2016-12-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203384-001	EPINASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	2016-12-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203384-001	EPINASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	2016-12-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203384-001	EPINASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	2016-12-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203384-001	EPINASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	2016-12-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203384-001	EPINASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	2016-12-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203384-001	EPINASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	2016-12-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203384-001	EPINASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	2016-12-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203384-001	EPINASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	2016-12-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203384-001	EPINASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	2016-12-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203384-001	EPINASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	2016-12-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203384-001	EPINASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	2016-12-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203384-001	EPINASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	2016-12-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203384-001	EPINASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	2016-12-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203384-001	EPINASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	2016-12-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203384-001	EPINASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	2016-12-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203384-001	EPINASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	2016-12-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203384-001	EPINASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	2016-12-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203384-001	EPINASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	2016-12-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203384-001	EPINASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	2016-12-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203384-001	EPINASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	2016-12-07	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203384-001	EPINASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS / OPHTHALMIC	2016-12-07	`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 brand name: EPINASTINE HYDROCHLORIDE generic name: EPINASTINE HYDROCHLORIDE

Documents#

Document, Submission type, Date table
Document	Submission type	Date
46106	ORIG	2016-12-09