Application 090848

Type: ANDA
Sponsor: BARR LABS 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 0.2% BASE	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
A090848-001	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC			2015-07-13

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090848-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-07-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090848-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-07-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090848-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-07-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090848-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-07-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090848-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-07-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090848-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-07-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090848-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-07-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090848-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-07-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090848-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-07-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090848-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-07-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090848-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-07-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090848-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-07-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090848-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-07-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090848-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-07-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090848-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-07-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090848-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-07-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090848-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-07-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090848-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2015-07-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090848-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-07-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090848-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-07-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090848-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-07-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090848-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2015-07-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090848-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2015-07-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090848-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2015-07-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090848-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2015-07-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090848-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2015-07-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090848-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2015-07-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090848-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-07-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090848-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-07-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090848-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-07-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090848-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-07-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090848-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-07-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090848-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-07-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090848-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-07-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090848-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-07-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090848-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-07-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090848-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-07-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090848-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-07-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090848-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-07-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090848-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-07-13	`cb3db0bc1861…`

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	A090848-001	AT	1	`74a2ff9319b5…`
2021-03-12 10:30 UTC	2021-03	A090848-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090848-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090848-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090848-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090848-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090848-001	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 1 of 4 · 72 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE OPHTHALMIC	Golden State Medical Supply, Inc.	50b02d58-dd82-6d0a-e063-6294a90a28fd	2026-04-30	Warnings	Name fallback brand name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Sportpharm LLC	f0cc699c-545d-4097-b85d-b67ba550863c	2026-04-24	Warnings	Name fallback brand name: OLOPATADINE HYDROCHLORIDE generic name: OLOPATADINE HYDROCHLORIDE
Retaine Allergy	OLOPATADINE HYDROCHLORIDE	OCuSOFT LLC	e0a01606-275d-448c-8838-ca46f1e612e5	2026-04-23	Warnings	Name fallback generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Best Choice	04c7b08c-52c1-427c-8b8f-fe67444fbca4	2026-04-22	Warnings	Name fallback brand name: OLOPATADINE HYDROCHLORIDE generic name: OLOPATADINE HYDROCHLORIDE
Olopatadine Hydrochloride Ophthalmic Solution	OLOPATADINE HYDROCHLORIDE	Dr. Reddy's Laboratories Inc.	5295f8a2-4e0d-4b6e-9807-e2f36b1d5d15	2026-04-15	Warnings	Name fallback generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	BluePoint Laboratories	3e86783f-0001-625f-e063-6294a90acd20	2026-03-25	Warnings	Name fallback brand name: OLOPATADINE HYDROCHLORIDE generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Somerset Therapeutics, LLC	6ee9f8f5-973c-4c71-8069-e76cd87b07dc	2026-03-25	Warnings	Name fallback brand name: OLOPATADINE HYDROCHLORIDE generic name: OLOPATADINE HYDROCHLORIDE
Olopatadine Hydrochloride	OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION	RUGBY LABORATORIES	96ad3623-f7cc-4c1c-aa65-d89077873b69	2026-02-24	Warnings	Name fallback brand name: Olopatadine Hydrochloride
Eye Allergy Itch Relief	OLOPATADINE HYDROCHLORIDE	CARDINAL HEALTH 110, LLC. DBA LEADER	5d79fc06-a25f-debb-f08b-523ff26df900	2026-02-24	Warnings	Name fallback generic name: OLOPATADINE HYDROCHLORIDE
Olopatadine Hydrochloride	OLOPATADINE HYDROCHLORIDE	Rugby Laboratories	95424539-7883-2da3-8a46-3d1a19259e15	2026-02-17	Warnings	Name fallback brand name: Olopatadine Hydrochloride generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	AmerisourceBergen Drug Corp	18f851e3-24c6-44fd-8376-0f5418ded9a9	2026-02-16	Warnings	Name fallback brand name: OLOPATADINE HYDROCHLORIDE generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE OPHTHALMIC	AmerisourceBergen Drug Corp	ea97d3d8-dc96-4c40-91e7-f076c588bf12	2026-02-16	Warnings	Name fallback brand name: OLOPATADINE HYDROCHLORIDE
Eye Allergy Itch and Redness Relief	OLOPATADINE HYDROCHLORIDE	CARDINAL HEALTH 110, LLC. DBA LEADER	5255d142-7d04-ab80-fa97-b11c4486e42c	2026-02-13	Warnings	Name fallback generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	YYBA Corp	47f8ae9b-d92b-4bcb-e063-6294a90af45a	2026-02-03	Warnings	Name fallback brand name: OLOPATADINE HYDROCHLORIDE generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	GLENMARK THERAPEUTICS INC., USA	07e8b359-d4ae-4b5b-81dc-c7e57e172c58	2026-01-27	Warnings	Name fallback brand name: OLOPATADINE HYDROCHLORIDE generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE OPHTHALMIC	GLENMARK THERAPEUTICS INC., USA	a80c3fd2-47b7-4ed0-b862-9c5099684607	2026-01-27	Warnings	Name fallback brand name: OLOPATADINE HYDROCHLORIDE
Olopatadine HCl	OLOPATADINE HYDROCHLORIDE	Rugby Laboratories	edb068e2-1835-483e-e59c-bcbe13b66d76	2026-01-22	Warnings	Name fallback generic name: OLOPATADINE HYDROCHLORIDE
PATADAY ONCE DAILY RELIEF	OLOPATADINE HYDROCHLORIDE	Alcon Laboratories, Inc.	1c7d2342-ba1c-4244-9814-d92a05725d4e	2026-01-20	Warnings	Name fallback generic name: OLOPATADINE HYDROCHLORIDE
PATADAY TWICE A DAY RELIEF	OLOPATADINE HYDROCHLORIDE	Alcon Laboratories, Inc.	b7a24375-25df-4405-aa7c-34c46af51194	2026-01-20	Warnings	Name fallback generic name: OLOPATADINE HYDROCHLORIDE
PATADAY ONCE DAILY RELIEF	OLOPATADINE HYDROCHLORIDE	Alcon Laboratories, Inc.	6d07a5d6-265c-4735-97b3-8a2575b276cb	2026-01-20	Warnings	Name fallback generic name: OLOPATADINE HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-7684	Olopatadine Hydrochloride	Olopatadine Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7684	Olopatadine Hydrochloride	Olopatadine Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7684	Olopatadine Hydrochloride	Olopatadine Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
67172-504	Clear Eyes	Olopatadine hydrochloride	Prestige Brands Holdings, Inc.	ANDA	Current
67172-504	Clear Eyes Once Daily Eye Allergy Itch Relief	Olopatadine hydrochloride	Prestige Brands Holdings, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
39613	ORIG	2015-07-22
31503	ORIG	2015-07-15