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PATANASE	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2008-04-15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N021861-001	PATANASE	0.665MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2008-04-15	`84e616aacf4f…`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N021861-001	PATANASE	0.665MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2008-04-15	`caaa826d4ba7…`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UTC	2026-02	N021861-001	PATANASE	0.665MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2008-04-15	`011fe1cb6892…`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this ZIP	2025-12	N021861-001	PATANASE	0.665MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2008-04-15	`31067a03dcf5…`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 3 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	Bryant Ranch Prepack	272e8f56-ee4e-456f-ab98-3e40f657c630	2024-05-10	Warnings, Adverse reactions	Name fallback generic name: OLOPATADINE HYDROCHLORIDE
olopatadine hydrochloride	OLOPATADINE HYDROCHLORIDE	Padagis Israel Pharmaceuticals Ltd	126ff6eb-62ae-46f2-ab1e-7ac19346c36b	2023-09-01	Warnings, Adverse reactions	Name fallback generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Amerisource Bergen	067baa0b-5c01-4908-92de-ad79c73d2c37	2023-07-10	Warnings	Name fallback generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Amerisource Bergen	f3b054d2-4abd-4a1f-910d-0c61e2a24fbf	2023-07-10	Warnings	Name fallback generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	A-S Medication Solutions	c4ad0d8e-7539-4dc8-825d-d5e9ff27e488	2023-02-02	Warnings	Name fallback generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Meijer	09dda927-4191-425c-936c-1acbf94ef657	2022-09-03	Warnings	Name fallback generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Meijer	d15e4288-c315-48dc-b120-6836a4b4b8c6	2022-08-11	Warnings	Name fallback generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Wal-Mart Stores, Inc.	06467360-22fe-4a48-b234-06dbff30e853	2022-06-21	Warnings	Name fallback generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	BluePoint Laboratories	dbd28ee2-bbb5-a4b1-e053-2a95a90afff4	2022-04-08	Warnings	Name fallback generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	WALGREEN CO.	da0f9110-8362-497c-a209-c33a8fa8d995	2021-11-11	Warnings	Name fallback generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	WALGREEN CO.	637cb721-53bf-4938-80a6-5760980098eb	2021-11-11	Warnings	Name fallback generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Harris Teeter	b680db29-d05b-62c3-e053-2995a90a2921	2021-10-01	Warnings	Name fallback generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Harris Teeter	b631055d-c279-215f-e053-2a95a90a8c9c	2021-09-30	Warnings	Name fallback generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Wal-Mart Stores, Inc.	34723580-dfd0-4ab7-a757-d86570261e7f	2021-09-20	Warnings	Name fallback generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Retail Business Services, LLC.	bd2deb79-c135-2d3f-e053-2a95a90a9322	2021-05-07	Warnings	Name fallback generic name: OLOPATADINE HYDROCHLORIDE
Olopatadine Hydrochloride	OLOPATADINE HYDROCHLORIDE	Amneal Pharmaceuticals LLC	806e8d0f-ff42-4d6e-b840-49e3bf867cb5	2021-04-30	Warnings, Adverse reactions	Name fallback generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Retail Business Services, LLC.	bca27f6a-d1b1-1d6a-e053-2995a90a37b5	2021-04-01	Warnings	Name fallback generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Allwell Health Inc	12d48ef6-ccf1-4bc3-8469-0061bb083f7c	2021-03-01	Warnings	Name fallback generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Kroger Company	dc80e8b0-21f7-4b12-93cb-738619f2be7c	2021-01-28	Warnings	Name fallback generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Kroger Company	f8993bc2-0fb3-4802-8187-3677d0e58026	2021-01-28	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