Application 091572

Type: ANDA
Sponsor: APOTEX INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	SPRAY, METERED;NASAL	0.665MG/SPRAY	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
A091572-001	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB		2014-10-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A091572-001	AB

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	A091572-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	2014-10-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091572-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	2014-10-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091572-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	2014-10-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091572-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	2014-10-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091572-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	2014-10-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091572-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	2014-10-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091572-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	2014-10-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091572-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	2014-10-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091572-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	2014-10-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091572-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	2014-10-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091572-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	2014-10-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091572-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	2014-10-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091572-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	2014-10-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091572-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	2014-10-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091572-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	2014-10-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091572-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	2014-10-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091572-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	2014-10-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091572-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	2014-10-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091572-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	2014-10-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091572-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	2014-10-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091572-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	2014-10-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091572-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	2014-10-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091572-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	2014-10-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091572-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	2014-10-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091572-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	2014-10-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091572-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	2014-10-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091572-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	2014-10-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091572-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	2014-10-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091572-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	2014-10-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091572-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	2014-10-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091572-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	2014-10-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091572-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	2014-10-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091572-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	2014-10-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091572-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	2014-10-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091572-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	2014-10-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091572-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	2014-10-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091572-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	2014-10-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091572-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	2014-10-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091572-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	2014-10-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091572-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	2014-10-08	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A091572-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091572-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091572-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091572-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091572-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091572-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091572-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091572-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091572-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091572-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091572-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091572-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091572-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091572-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091572-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091572-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091572-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091572-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091572-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091572-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091572-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091572-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091572-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091572-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091572-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091572-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091572-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091572-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091572-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091572-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091572-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091572-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091572-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091572-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091572-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091572-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091572-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091572-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091572-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091572-001	AB	1	`f41ea6bd6efb…`

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 2 of 4 · 70 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PATADAY ONCE DAILY RELIEF	OLOPATADINE HYDROCHLORIDE	Alcon Laboratories, Inc.	6d07a5d6-265c-4735-97b3-8a2575b276cb	2026-01-20	Warnings	Name fallback generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	WALGREEN COMPANY	26703751-00c4-451b-a5be-242da9cd2b88	2025-12-16	Warnings	Name fallback brand name: OLOPATADINE HYDROCHLORIDE generic name: OLOPATADINE HYDROCHLORIDE
Olopatadine hydrochloride	OLOPATADINE HYDROCHLORIDE	Golden State Medical Supply, Inc.	ec0c8c56-68d2-e63e-e053-2995a90a8db2	2025-11-24	Warnings	Name fallback brand name: Olopatadine hydrochloride generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	A-S Medication Solutions	7c89196a-cf74-4ce3-a9fd-b3d42a9e2a19	2025-11-18	Warnings	Name fallback brand name: OLOPATADINE HYDROCHLORIDE generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Aurohealth LLC	b022f8f9-ad3d-4a6d-96aa-24c1ccd1f422	2025-10-09	Warnings	Name fallback brand name: OLOPATADINE HYDROCHLORIDE generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Aurohealth LLC	94b1fe3b-6a9b-475a-9c65-1700ce1c2183	2025-10-09	Warnings	Name fallback brand name: OLOPATADINE HYDROCHLORIDE generic name: OLOPATADINE HYDROCHLORIDE
EQUATE OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	WAL-MART STORES, INC.,	3ffd2bec-c5d1-47ff-ae5f-bc20e9c1de84	2025-08-19	Warnings	Name fallback generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Allegiant Health	fdb808ef-9d5f-4bc3-86e7-f519b5c75a46	2025-05-05	Warnings	Name fallback brand name: OLOPATADINE HYDROCHLORIDE generic name: OLOPATADINE HYDROCHLORIDE
Olopatadine Hydrochloride	OLOPATADINE HYDROCHLORIDE	TARGET CORPORATION	879f9cf8-d6bb-483b-a6a7-28aba8806493	2025-04-14	Warnings	Name fallback brand name: Olopatadine Hydrochloride generic name: OLOPATADINE HYDROCHLORIDE
LEADER OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	CARDINAL HEALTH	71d922d2-22a5-4103-a3eb-126094ee8ef5	2025-04-14	Warnings	Name fallback generic name: OLOPATADINE HYDROCHLORIDE
olopatadine hydrochloride	OLOPATADINE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	7c86e2d4-2d37-4ccf-9227-820a50637778	2025-04-04	Warnings	Name fallback brand name: olopatadine hydrochloride generic name: OLOPATADINE HYDROCHLORIDE
olopatadine hydrochloride	OLOPATADINE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	0988e6e2-59a9-47dc-9386-9e9ea877e6c1	2025-04-04	Warnings	Name fallback brand name: olopatadine hydrochloride generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE OPHTHALMIC	Strategic Sourcing Services LLC	05ab7b8d-c828-4246-b809-1eb3e4b4129f	2025-02-07	Warnings	Name fallback brand name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Bausch & Lomb Incorporated	9e4c86f3-e674-4727-a136-6735591ef816	2025-01-30	Warnings	Name fallback brand name: OLOPATADINE HYDROCHLORIDE generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Bausch & Lomb Incorporated	c420fd56-adea-4796-adaa-977b91fbf20a	2025-01-30	Warnings	Name fallback brand name: OLOPATADINE HYDROCHLORIDE generic name: OLOPATADINE HYDROCHLORIDE
Olopatadine Hydrochloride	OLOPATADINE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	bd1f9779-d048-46ff-a570-ce3ad92715e7	2024-12-17	Warnings	Name fallback brand name: Olopatadine Hydrochloride generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	RITE AID CORPORATION	1ce23269-9678-58be-e063-6294a90aa1d3	2024-10-22	Warnings	Name fallback brand name: OLOPATADINE HYDROCHLORIDE generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	RITE AID CORPORATION	1ce2f408-6eff-ca83-e063-6394a90a6d1a	2024-10-22	Warnings	Name fallback brand name: OLOPATADINE HYDROCHLORIDE generic name: OLOPATADINE HYDROCHLORIDE
Olopatadine Hydrochloride	OLOPATADINE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ba550d08-a2de-45e7-b053-6bbecdff138b	2024-10-09	Warnings	Name fallback brand name: Olopatadine Hydrochloride generic name: OLOPATADINE HYDROCHLORIDE
Olopatadine Hydrochloride	OLOPATADINE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	75823e5d-562a-43c2-8365-6f3f9484c9bf	2024-10-09	Warnings	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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
60505-0845	Olopatadine Hydrochloride	olopatadine hydrochloride	Apotex Corp.	ANDA	Current
60505-0845	Olopatadine Hydrochloride	olopatadine hydrochloride	Apotex Corp.	ANDA	Current
60505-0845	Olopatadine Hydrochloride	olopatadine hydrochloride	Apotex Corp.	ANDA	Current
60505-0845	Olopatadine Hydrochloride	olopatadine hydrochloride	Apotex Corp.	ANDA	Current