Application 206087

Type: ANDA
Sponsor: CIPLA

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
A206087-001	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC			2017-12-05

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	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2017-12-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2017-12-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2017-12-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2017-12-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`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	A206087-001	AT	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A206087-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206087-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206087-001	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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	WALGREEN COMPANY	26703751-00c4-451b-a5be-242da9cd2b88	2025-12-16	Warnings	Exact identifier application applno (ANDA): 206087 application number: ANDA206087
EQUATE OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	WAL-MART STORES, INC.,	3ffd2bec-c5d1-47ff-ae5f-bc20e9c1de84	2025-08-19	Warnings	Exact identifier application applno (ANDA): 206087 application number: ANDA206087
Olopatadine Hydrochloride Ophthalmic Solution	OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION	TARGET CORPORATION	355df5ce-95e2-4d05-9114-a3190d934d3a	2025-04-14	Warnings	Exact identifier application applno (ANDA): 206087 application number: ANDA206087
LEADER OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	CARDINAL HEALTH	71d922d2-22a5-4103-a3eb-126094ee8ef5	2025-04-14	Warnings	Exact identifier application applno (ANDA): 206087 application number: ANDA206087
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Bausch & Lomb Incorporated	9e4c86f3-e674-4727-a136-6735591ef816	2025-01-30	Warnings	Exact identifier application applno (ANDA): 206087 application number: ANDA206087
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Bausch & Lomb Incorporated	c420fd56-adea-4796-adaa-977b91fbf20a	2025-01-30	Warnings	Exact identifier application applno (ANDA): 206087 application number: ANDA206087

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69097-276	Olopatadine Hydrochloride	Olopatadine Hydrochloride Ophthalmic Solution	Cipla USA Inc.	ANDA	Current
69097-600	Olopatadine Hydrochloride	Olopatadine Hydrochloride	Cipla USA Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
48976	ORIG	2017-07-13