Application 204532

Type: ANDA
Sponsor: AKORN INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	SOLUTION/DROPS;OPHTHALMIC	EQ 0.1% BASE	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
A204532-001	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC			2017-01-10

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 · 43 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
2026-09-14 22:38:34	2026-08	A204532-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-01-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204532-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-01-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204532-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-01-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204532-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-01-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204532-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-01-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204532-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-01-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204532-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-01-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204532-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-01-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204532-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-01-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204532-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-01-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204532-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-01-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204532-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-01-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204532-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-01-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204532-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-01-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204532-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-01-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204532-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-01-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204532-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-01-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204532-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-01-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204532-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-01-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204532-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2017-01-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204532-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-01-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204532-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-01-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204532-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2017-01-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204532-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2017-01-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204532-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2017-01-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204532-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2017-01-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204532-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2017-01-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204532-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2017-01-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204532-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2017-01-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204532-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-01-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204532-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-01-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204532-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-01-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204532-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-01-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204532-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-01-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204532-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-01-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204532-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-01-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204532-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-01-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204532-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-01-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204532-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-01-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204532-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-01-10	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A204532-001	AT	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204532-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204532-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204532-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204532-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204532-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204532-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204532-001	AT	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 3 of 4 · 70 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
olopatadine hydrochloride	OLOPATADINE HYDROCHLORIDE	Bryant Ranch Prepack	db024b9c-681f-4503-9fda-1eaa1add4746	2024-08-15	Warnings, Adverse reactions	Name fallback brand name: olopatadine hydrochloride generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	TOPCO ASSOCIATES LLC	1932ee68-43a5-6474-e063-6294a90aacaf	2024-06-14	Warnings	Name fallback brand name: OLOPATADINE HYDROCHLORIDE generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	TOPCO ASSOCIATES LLC	f5bddc73-1899-b5f0-e053-2995a90ab98f	2024-06-14	Warnings	Name fallback brand name: OLOPATADINE HYDROCHLORIDE generic name: OLOPATADINE HYDROCHLORIDE
Olopatadine Hydrochloride	OLOPATADINE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ac82e6ea-5694-4f48-819b-91fc567ceaf1	2024-06-11	Warnings	Name fallback brand name: Olopatadine Hydrochloride generic name: OLOPATADINE HYDROCHLORIDE
olopatadine hydrochloride	OLOPATADINE HYDROCHLORIDE	Bryant Ranch Prepack	272e8f56-ee4e-456f-ab98-3e40f657c630	2024-05-10	Warnings, Adverse reactions	Name fallback brand name: olopatadine hydrochloride generic name: OLOPATADINE HYDROCHLORIDE
olopatadine hydrochloride	OLOPATADINE HYDROCHLORIDE	Padagis Israel Pharmaceuticals Ltd	126ff6eb-62ae-46f2-ab1e-7ac19346c36b	2023-09-01	Warnings, Adverse reactions	Name fallback brand name: olopatadine hydrochloride generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Amerisource Bergen	067baa0b-5c01-4908-92de-ad79c73d2c37	2023-07-10	Warnings	Name fallback brand name: OLOPATADINE HYDROCHLORIDE generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Amerisource Bergen	f3b054d2-4abd-4a1f-910d-0c61e2a24fbf	2023-07-10	Warnings	Name fallback brand name: OLOPATADINE HYDROCHLORIDE generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	A-S Medication Solutions	c4ad0d8e-7539-4dc8-825d-d5e9ff27e488	2023-02-02	Warnings	Name fallback brand name: OLOPATADINE HYDROCHLORIDE generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Meijer	09dda927-4191-425c-936c-1acbf94ef657	2022-09-03	Warnings	Name fallback brand name: OLOPATADINE HYDROCHLORIDE generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Meijer	d15e4288-c315-48dc-b120-6836a4b4b8c6	2022-08-11	Warnings	Name fallback brand name: OLOPATADINE HYDROCHLORIDE generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Wal-Mart Stores, Inc.	06467360-22fe-4a48-b234-06dbff30e853	2022-06-21	Warnings	Name fallback brand name: OLOPATADINE HYDROCHLORIDE generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	BluePoint Laboratories	dbd28ee2-bbb5-a4b1-e053-2a95a90afff4	2022-04-08	Warnings	Name fallback brand name: OLOPATADINE HYDROCHLORIDE generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	WALGREEN CO.	da0f9110-8362-497c-a209-c33a8fa8d995	2021-11-11	Warnings	Name fallback brand name: OLOPATADINE HYDROCHLORIDE generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	WALGREEN CO.	637cb721-53bf-4938-80a6-5760980098eb	2021-11-11	Warnings	Name fallback brand name: OLOPATADINE HYDROCHLORIDE generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Harris Teeter	b680db29-d05b-62c3-e053-2995a90a2921	2021-10-01	Warnings	Name fallback brand name: OLOPATADINE HYDROCHLORIDE generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Harris Teeter	b631055d-c279-215f-e053-2a95a90a8c9c	2021-09-30	Warnings	Name fallback brand name: OLOPATADINE HYDROCHLORIDE generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Wal-Mart Stores, Inc.	34723580-dfd0-4ab7-a757-d86570261e7f	2021-09-20	Warnings	Name fallback brand name: OLOPATADINE HYDROCHLORIDE generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Retail Business Services, LLC.	bd2deb79-c135-2d3f-e053-2a95a90a9322	2021-05-07	Warnings	Name fallback brand name: OLOPATADINE HYDROCHLORIDE generic name: OLOPATADINE HYDROCHLORIDE
Olopatadine Hydrochloride	OLOPATADINE HYDROCHLORIDE	Amneal Pharmaceuticals LLC	806e8d0f-ff42-4d6e-b840-49e3bf867cb5	2021-04-30	Warnings, Adverse reactions	Name fallback brand name: Olopatadine Hydrochloride generic name: OLOPATADINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
17478-105	Olopatadine	Olopatadine Hydrochloride	Akorn, Inc.	ANDA	Current
17478-105	Olopatadine	Olopatadine Hydrochloride	Akorn, Inc.	ANDA	Current
17478-105	Olopatadine	Olopatadine Hydrochloride	Akorn	ANDA	Current
17478-308	Olopatadine	Olopatadine Hydrochloride	Akorn, Inc.	ANDA	Current
17478-308	Olopatadine	Olopatadine Hydrochloride	Akorn	ANDA	Current
50090-3552	Olopatadine	Olopatadine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3552	Olopatadine	Olopatadine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3552	Olopatadine	Olopatadine Hydrochloride	A-S Medication Solutions	ANDA	Current
51407-499	Olopatadine	Olopatadine Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
51407-499	Olopatadine	Olopatadine Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
51407-499	Olopatadine	Olopatadine Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
51407-499	Olopatadine	Olopatadine Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
51407-499	Olopatadine	Olopatadine Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
60429-957	Olopatadine	Olopatadine Hydrochloride	Golden State Medical Supply, Inc	ANDA	Current
60429-957	Olopatadine	Olopatadine Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
60429-957	Olopatadine	Olopatadine Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
60429-957	Olopatadine	Olopatadine Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current