Application 021861

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PATANASE	OLOPATADINE HYDROCHLORIDE	SPRAY, METERED;NASAL	0.665MG/SPRAY	Yes	Yes

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
N021861-001	PATANASE	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2008-04-15

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021861-001	PATANASE	0.665MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2008-04-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021861-001	PATANASE	0.665MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2008-04-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021861-001	PATANASE	0.665MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2008-04-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021861-001	PATANASE	0.665MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2008-04-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021861-001	PATANASE	0.665MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2008-04-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021861-001	PATANASE	0.665MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2008-04-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021861-001	PATANASE	0.665MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2008-04-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021861-001	PATANASE	0.665MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2008-04-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL		RLD	2008-04-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL		RLD	2008-04-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL		RLD	2008-04-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL		RLD	2008-04-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL		RLD	2008-04-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL		RLD	2008-04-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL		RLD	2008-04-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL		RLD	2008-04-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2008-04-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2008-04-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2008-04-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2008-04-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2008-04-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2008-04-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2008-04-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2008-04-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2008-04-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2008-04-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2008-04-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2008-04-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2008-04-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL		RLD	2008-04-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL		RLD	2008-04-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL		RLD	2008-04-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL		RLD	2008-04-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL		RLD	2008-04-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL		RLD	2008-04-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL		RLD	2008-04-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2008-04-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2008-04-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2008-04-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2008-04-15	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021861-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021861-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021861-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021861-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021861-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021861-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021861-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021861-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021861-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021861-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021861-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021861-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021861-001	AB	1	`ea99ee380514…`
2023-05-13 08:27 UTC	2023-05	N021861-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021861-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021861-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021861-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021861-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021861-001	AB	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 90 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021861-001	8399508	2022-09-17	U-726		2013-03-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021861-001	7977376	2023-02-02		Drug product	2011-07-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021861-001	8399508*PED	2023-03-17		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021861-001	7977376*PED	2023-08-02		Pediatric extension		`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021861-001	8399508	2022-09-17	U-726		2013-03-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021861-001	7977376	2023-02-02		Drug product	2011-07-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021861-001	8399508*PED	2023-03-17		Pediatric extension		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021861-001	7977376*PED	2023-08-02		Pediatric extension		`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021861-001	8399508	2022-09-17	U-726		2013-03-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021861-001	7977376	2023-02-02		Drug product	2011-07-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021861-001	8399508*PED	2023-03-17		Pediatric extension		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021861-001	7977376*PED	2023-08-02		Pediatric extension		`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021861-001	8399508	2022-09-17	U-726		2013-03-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021861-001	7977376	2023-02-02		Drug product	2011-07-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021861-001	8399508*PED	2023-03-17		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021861-001	7977376*PED	2023-08-02		Pediatric extension		`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021861-001	8399508	2022-09-17	U-726		2013-03-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021861-001	7977376	2023-02-02		Drug product	2011-07-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021861-001	8399508*PED	2023-03-17		Pediatric extension		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021861-001	7977376*PED	2023-08-02		Pediatric extension		`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021861-001	8399508	2022-09-17	U-726		2013-03-26	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021861-001	7977376	2023-02-02		Drug product	2011-07-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021861-001	8399508*PED	2023-03-17		Pediatric extension		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021861-001	7977376*PED	2023-08-02		Pediatric extension		`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021861-001	8399508	2022-09-17	U-726		2013-03-26	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021861-001	7977376	2023-02-02		Drug product	2011-07-15	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021861-001	8399508*PED	2023-03-17		Pediatric extension		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021861-001	7977376*PED	2023-08-02		Pediatric extension		`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021861-001	8399508	2022-09-17	U-726		2013-03-26	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021861-001	7977376	2023-02-02		Drug product	2011-07-15	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021861-001	8399508*PED	2023-03-17		Pediatric extension		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021861-001	7977376*PED	2023-08-02		Pediatric extension		`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021861-001	8399508	2022-09-17	U-726		2013-03-26	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021861-001	7977376	2023-02-02		Drug product	2011-07-15	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021861-001	8399508*PED	2023-03-17		Pediatric extension		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021861-001	7977376*PED	2023-08-02		Pediatric extension		`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021861-001	8399508	2022-09-17	U-726		2013-03-26	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021861-001	7977376	2023-02-02		Drug product	2011-07-15	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021861-001	8399508*PED	2023-03-17		Pediatric extension		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021861-001	7977376*PED	2023-08-02		Pediatric extension		`c0c555d07b60…`

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 · 66 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	A-S Medication Solutions	7c89196a-cf74-4ce3-a9fd-b3d42a9e2a19	2025-11-18	Warnings	Name fallback generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Aurohealth LLC	b022f8f9-ad3d-4a6d-96aa-24c1ccd1f422	2025-10-09	Warnings	Name fallback generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Aurohealth LLC	94b1fe3b-6a9b-475a-9c65-1700ce1c2183	2025-10-09	Warnings	Name fallback 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 generic name: OLOPATADINE HYDROCHLORIDE
Olopatadine Hydrochloride	OLOPATADINE HYDROCHLORIDE	TARGET CORPORATION	879f9cf8-d6bb-483b-a6a7-28aba8806493	2025-04-14	Warnings	Name fallback 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 generic name: OLOPATADINE HYDROCHLORIDE
olopatadine hydrochloride	OLOPATADINE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	0988e6e2-59a9-47dc-9386-9e9ea877e6c1	2025-04-04	Warnings	Name fallback generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Bausch & Lomb Incorporated	9e4c86f3-e674-4727-a136-6735591ef816	2025-01-30	Warnings	Name fallback generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Bausch & Lomb Incorporated	c420fd56-adea-4796-adaa-977b91fbf20a	2025-01-30	Warnings	Name fallback generic name: OLOPATADINE HYDROCHLORIDE
Olopatadine Hydrochloride	OLOPATADINE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	bd1f9779-d048-46ff-a570-ce3ad92715e7	2024-12-17	Warnings	Name fallback generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	RITE AID CORPORATION	1ce23269-9678-58be-e063-6294a90aa1d3	2024-10-22	Warnings	Name fallback generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	RITE AID CORPORATION	1ce2f408-6eff-ca83-e063-6394a90a6d1a	2024-10-22	Warnings	Name fallback generic name: OLOPATADINE HYDROCHLORIDE
Olopatadine Hydrochloride	OLOPATADINE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ba550d08-a2de-45e7-b053-6bbecdff138b	2024-10-09	Warnings	Name fallback generic name: OLOPATADINE HYDROCHLORIDE
Olopatadine Hydrochloride	OLOPATADINE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	75823e5d-562a-43c2-8365-6f3f9484c9bf	2024-10-09	Warnings	Name fallback generic name: OLOPATADINE HYDROCHLORIDE
olopatadine hydrochloride	OLOPATADINE HYDROCHLORIDE	Bryant Ranch Prepack	db024b9c-681f-4503-9fda-1eaa1add4746	2024-08-15	Warnings, Adverse reactions	Name fallback generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	TOPCO ASSOCIATES LLC	1932ee68-43a5-6474-e063-6294a90aacaf	2024-06-14	Warnings	Name fallback generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	TOPCO ASSOCIATES LLC	f5bddc73-1899-b5f0-e053-2995a90ab98f	2024-06-14	Warnings	Name fallback generic name: OLOPATADINE HYDROCHLORIDE
Olopatadine Hydrochloride	OLOPATADINE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ac82e6ea-5694-4f48-819b-91fc567ceaf1	2024-06-11	Warnings	Name fallback 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 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0065-0332	PATANASE	olopatadine hydrochloride	Alcon Laboratories, Inc.	NDA	Current
0065-0332	PATANASE	olopatadine hydrochloride	Alcon Laboratories, Inc.	NDA	Current
0065-0332	PATANASE	olopatadine hydrochloride	Alcon Laboratories, Inc.	NDA	Current
0065-0332	PATANASE	olopatadine hydrochloride	Alcon Laboratories, Inc.	NDA	Current
0065-0332	PATANASE	olopatadine hydrochloride	Alcon Laboratories, Inc.	NDA	Current
0065-0332	PATANASE	olopatadine hydrochloride	Alcon Laboratories, Inc.	NDA	Current
0078-0834	PATANASE	olopatadine hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0834	PATANASE	olopatadine hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
61314-320	Olopatadine Hydrochloride	olopatadine hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
61314-320	Olopatadine Hydrochloride	olopatadine hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
61314-320	Olopatadine Hydrochloride	olopatadine hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
66749	SUPPL	2021-03-11
66550	SUPPL	2021-03-05
16475	SUPPL	2015-11-04
6327	SUPPL	2015-10-28
6326	SUPPL	2012-02-27
37779	SUPPL	2012-02-24
28731	SUPPL	2010-04-05
37778	SUPPL	2010-04-04
42330	ORIG	2010-03-19
28730	SUPPL	2010-01-26
37777	SUPPL	2009-12-02
37776	ORIG	2008-04-23
6325	ORIG	2008-04-22
53361	ORIG	1900-01-01
53360	ORIG	1900-01-01
53359	ORIG	1900-01-01
53358	ORIG	1900-01-01
53357	ORIG	1900-01-01
53356	ORIG	1900-01-01