Application 209995

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 0.2% BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A209995-001	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC			2019-04-04

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 · 42 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
2026-08-18 06:07:40	2026-07	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2019-04-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2019-04-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2019-04-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2019-04-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`e64feba35796…`

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	A209995-001	AT	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A209995-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209995-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209995-001	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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Best Choice	04c7b08c-52c1-427c-8b8f-fe67444fbca4	2026-04-22	Warnings	Exact identifier application applno (ANDA): 209995 application number: ANDA209995
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	A-S Medication Solutions	7c89196a-cf74-4ce3-a9fd-b3d42a9e2a19	2025-11-18	Warnings	Exact identifier application applno (ANDA): 209995 application number: ANDA209995 ndc (product): 50090-5613
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Aurohealth LLC	b022f8f9-ad3d-4a6d-96aa-24c1ccd1f422	2025-10-09	Warnings	Exact identifier application applno (ANDA): 209995 application number: ANDA209995 ndc (product): 58602-007
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	RITE AID CORPORATION	1ce2f408-6eff-ca83-e063-6394a90a6d1a	2024-10-22	Warnings	Exact identifier application applno (ANDA): 209995 application number: ANDA209995
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	TOPCO ASSOCIATES LLC	1932ee68-43a5-6474-e063-6294a90aacaf	2024-06-14	Warnings	Exact identifier application applno (ANDA): 209995 application number: ANDA209995
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Amerisource Bergen	067baa0b-5c01-4908-92de-ad79c73d2c37	2023-07-10	Warnings	Exact identifier application applno (ANDA): 209995 application number: ANDA209995 ndc (product): 46122-671
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Meijer	d15e4288-c315-48dc-b120-6836a4b4b8c6	2022-08-11	Warnings	Exact identifier application applno (ANDA): 209995 application number: ANDA209995 ndc (product): 79481-1001
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	BluePoint Laboratories	dbd28ee2-bbb5-a4b1-e053-2a95a90afff4	2022-04-08	Warnings	Exact identifier application applno (ANDA): 209995 application number: ANDA209995 ndc (product): 68001-530
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	WALGREEN CO.	da0f9110-8362-497c-a209-c33a8fa8d995	2021-11-11	Warnings	Exact identifier application applno (ANDA): 209995 application number: ANDA209995 ndc (product): 0363-8022
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Harris Teeter	b680db29-d05b-62c3-e053-2995a90a2921	2021-10-01	Warnings	Exact identifier application applno (ANDA): 209995 application number: ANDA209995 ndc (product): 72036-009
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Wal-Mart Stores, Inc.	34723580-dfd0-4ab7-a757-d86570261e7f	2021-09-20	Warnings	Exact identifier application applno (ANDA): 209995 application number: ANDA209995 ndc (product): 79903-001
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Retail Business Services, LLC.	bca27f6a-d1b1-1d6a-e053-2995a90a37b5	2021-04-01	Warnings	Exact identifier application applno (ANDA): 209995 application number: ANDA209995 ndc (product): 72476-851
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Allwell Health Inc	12d48ef6-ccf1-4bc3-8469-0061bb083f7c	2021-03-01	Warnings	Exact identifier application applno (ANDA): 209995 application number: ANDA209995 ndc (product): 80539-001
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Kroger Company	dc80e8b0-21f7-4b12-93cb-738619f2be7c	2021-01-28	Warnings	Exact identifier application applno (ANDA): 209995 application number: ANDA209995 ndc (product): 30142-026
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Aurohealth LLC	5f9e93e7-ff12-484d-add8-4f834193c1c6	2020-10-09	Warnings	Exact identifier application applno (ANDA): 209995 application number: ANDA209995 ndc (product): 58602-013
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Aurohealth LLC	aa763fdb-22a8-4975-b634-d4e6e105f588	2020-08-28	Warnings	Exact identifier application applno (ANDA): 209995 application number: ANDA209995 ndc (product): 58602-010

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 38 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0363-8022	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	WALGREEN CO.	ANDA	Current
0363-8022	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	WALGREEN CO.	ANDA	Current
0363-8022	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	WALGREEN CO.	ANDA	Current
0363-8022	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	WALGREEN CO.	ANDA	Current
0363-8022	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	WALGREEN CO.	ANDA	Current
30142-026	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Kroger Company	ANDA	Current
30142-026	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Kroger Company	ANDA	Current
30142-026	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Kroger Company	ANDA	Current
46122-671	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Amerisource Bergen	ANDA	Current
46122-671	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Amerisource Bergen	ANDA	Current
46122-671	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Amerisource Bergen	ANDA	Current
46122-671	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Amerisource Bergen	ANDA	Current
50090-5613	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	A-S Medication Solutions	ANDA	Current
50090-5613	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	A-S Medication Solutions	ANDA	Current
58602-007	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Aurohealth LLC	ANDA	Current
58602-007	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Aurohealth LLC	ANDA	Current
58602-007	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Aurohealth LLC	ANDA	Current
58602-007	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Aurohealth LLC	ANDA	Current
58602-007	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Aurohealth LLC	ANDA	Current
58602-010	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Aurohealth LLC	ANDA	Current
58602-010	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Aurohealth LLC	ANDA	Current
58602-013	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Aurohealth LLC	ANDA	Current
58602-013	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Aurohealth LLC	ANDA	Current
58602-013	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Aurohealth LLC	ANDA	Current
59651-066	Olopatadine Hydrochloride	Olopatadine Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
59651-066	Olopatadine Hydrochloride	Olopatadine Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
68001-530	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	BluePoint Laboratories	ANDA	Current
72036-009	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Harris Teeter	ANDA	Current
72036-009	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Harris Teeter	ANDA	Current
72476-851	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Retail Business Services, LLC.	ANDA	Current
79481-1001	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Meijer	ANDA	Current
79481-1001	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Meijer	ANDA	Current
79481-1001	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Meijer	ANDA	Current
79481-1001	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Meijer	ANDA	Current
79903-001	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Wal-Mart Stores, Inc.	ANDA	Current
79903-001	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Wal-Mart Inc.	ANDA	Current
79903-001	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Wal-Mart Inc.	ANDA	Current
80539-001	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Allwell Health Inc	ANDA	Current