Application 204812

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

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 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
A204812-001	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC			2015-12-18

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	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2015-12-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2015-12-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2015-12-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2015-12-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`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	A204812-001	AT	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A204812-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204812-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204812-001	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 1 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Sportpharm LLC	f0cc699c-545d-4097-b85d-b67ba550863c	2026-04-24	Warnings	Exact identifier application applno (ANDA): 204812 application number: ANDA204812
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Aurohealth LLC	94b1fe3b-6a9b-475a-9c65-1700ce1c2183	2025-10-09	Warnings	Exact identifier application applno (ANDA): 204812 application number: ANDA204812 ndc (product): 58602-006
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	RITE AID CORPORATION	1ce23269-9678-58be-e063-6294a90aa1d3	2024-10-22	Warnings	Exact identifier application applno (ANDA): 204812 application number: ANDA204812
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	TOPCO ASSOCIATES LLC	f5bddc73-1899-b5f0-e053-2995a90ab98f	2024-06-14	Warnings	Exact identifier application applno (ANDA): 204812 application number: ANDA204812
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Amerisource Bergen	f3b054d2-4abd-4a1f-910d-0c61e2a24fbf	2023-07-10	Warnings	Exact identifier application applno (ANDA): 204812 application number: ANDA204812 ndc (product): 46122-672
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	A-S Medication Solutions	c4ad0d8e-7539-4dc8-825d-d5e9ff27e488	2023-02-02	Warnings	Exact identifier application applno (ANDA): 204812 application number: ANDA204812
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Meijer	09dda927-4191-425c-936c-1acbf94ef657	2022-09-03	Warnings	Exact identifier application applno (ANDA): 204812 application number: ANDA204812 ndc (product): 79481-1000
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Wal-Mart Stores, Inc.	06467360-22fe-4a48-b234-06dbff30e853	2022-06-21	Warnings	Exact identifier application applno (ANDA): 204812 application number: ANDA204812 ndc (product): 79903-000
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	WALGREEN CO.	637cb721-53bf-4938-80a6-5760980098eb	2021-11-11	Warnings	Exact identifier application applno (ANDA): 204812 application number: ANDA204812 ndc (product): 0363-0200
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Harris Teeter	b631055d-c279-215f-e053-2a95a90a8c9c	2021-09-30	Warnings	Exact identifier application applno (ANDA): 204812 application number: ANDA204812 ndc (product): 72036-008
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Retail Business Services, LLC.	bd2deb79-c135-2d3f-e053-2a95a90a9322	2021-05-07	Warnings	Exact identifier application applno (ANDA): 204812 application number: ANDA204812 ndc (product): 72476-852
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Kroger Company	f8993bc2-0fb3-4802-8187-3677d0e58026	2021-01-28	Warnings	Exact identifier application applno (ANDA): 204812 application number: ANDA204812 ndc (product): 30142-064
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Aurohealth LLC	c12af544-995a-43d7-8404-94906d52fa07	2020-08-28	Warnings	Exact identifier application applno (ANDA): 204812 application number: ANDA204812 ndc (product): 58602-009
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Aurohealth LLC	8fb16daa-340d-45a0-ab22-e028d77e2476	2020-08-21	Warnings	Exact identifier application applno (ANDA): 204812 application number: ANDA204812 ndc (product): 58602-012

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 33 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0363-0200	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	WALGREEN CO.	ANDA	Current
0363-0200	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	WALGREEN CO.	ANDA	Current
0363-0200	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	WALGREEN CO.	ANDA	Current
0363-0200	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	WALGREEN CO.	ANDA	Current
30142-064	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Kroger Company	ANDA	Current
30142-064	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Kroger Company	ANDA	Current
30142-064	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Kroger Company	ANDA	Current
30142-064	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Kroger Company	ANDA	Current
46122-672	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Amerisource Bergen	ANDA	Current
46122-672	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Amerisource Bergen	ANDA	Current
46122-672	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Amerisource Bergen	ANDA	Current
58602-006	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Aurohealth LLC	ANDA	Current
58602-006	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Aurohealth LLC	ANDA	Current
58602-006	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Aurohealth LLC	ANDA	Current
58602-006	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Aurohealth LLC	ANDA	Current
58602-006	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Aurohealth LLC	ANDA	Current
58602-009	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Aurohealth LLC	ANDA	Current
58602-009	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Aurohealth LLC	ANDA	Current
58602-012	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Aurohealth LLC	ANDA	Current
65862-757	Olopatadine Hydrochloride	Olopatadine Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-757	Olopatadine Hydrochloride	Olopatadine Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
72036-008	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Harris Teeter	ANDA	Current
72036-008	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Harris Teeter	ANDA	Current
72189-053	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Direct Rx	ANDA	Current
72476-852	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Retail Business Services, LLC.	ANDA	Current
79481-1000	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Meijer	ANDA	Current
79481-1000	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Meijer	ANDA	Current
79481-1000	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Meijer	ANDA	Current
79481-1000	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Meijer	ANDA	Current
79903-000	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Wal-Mart Inc.	ANDA	Current
79903-000	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Wal-Mart Inc.	ANDA	Current
79903-000	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Wal-Mart Stores, Inc.	ANDA	Current
79903-000	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Wal-Mart Stores, Inc.	ANDA	Current