Application 020688

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PATADAY TWICE DAILY RELIEF	OLOPATADINE HYDROCHLORIDE	SOLUTION/DROPS;OPHTHALMIC	EQ 0.1% BASE	Yes	Yes

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
N020688-001	PATADAY TWICE DAILY RELIEF	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020688-001	PATANOL	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-12-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020688-001	PATANOL	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-12-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020688-001	PATANOL	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-12-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020688-001	PATANOL	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-12-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`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	N020688-001	AT	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N020688-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020688-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020688-001	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PATADAY TWICE A DAY RELIEF	OLOPATADINE HYDROCHLORIDE	Alcon Laboratories, Inc.	b7a24375-25df-4405-aa7c-34c46af51194	2026-01-20	Warnings	Exact identifier application applno (NDA): 020688 application number: NDA020688 ndc (product): 0065-4274

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
0065-0271	Patanol	olopatadine hydrochloride	Alcon Laboratories, Inc.	NDA	Current
0065-0271	Patanol	olopatadine hydrochloride	Alcon Laboratories, Inc.	NDA	Current
0065-0271	Patanol	olopatadine hydrochloride	Alcon Laboratories, Inc.	NDA	Current
0065-4274	PATADAY TWICE A DAY RELIEF	OLOPATADINE HYDROCHLORIDE	Alcon Laboratories, Inc.	NDA	Current
0065-4274	PATADAY TWICE A DAY RELIEF	OLOPATADINE HYDROCHLORIDE	Alcon Laboratories, Inc.	NDA	Current
0065-4274	PATADAY TWICE A DAY RELIEF	OLOPATADINE HYDROCHLORIDE	Alcon Laboratories, Inc.	NDA	Current
0065-4274	PATADAY TWICE A DAY RELIEF	OLOPATADINE HYDROCHLORIDE	Alcon Laboratories, Inc.	NDA	Current
50090-0593	Patanol	olopatadine hydrochloride	A-S Medication Solutions	NDA	Current
61314-271	olopatadine hydrochloride	olopatadine hydrochloride	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
61314-271	olopatadine hydrochloride	olopatadine hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
61314-271	olopatadine hydrochloride	olopatadine hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82100	SUPPL	2025-05-01
81935	SUPPL	2025-04-21
70717	SUPPL	2022-04-07
64782	SUPPL	2020-10-01
61901	SUPPL	2020-02-14
61898	SUPPL	2020-02-14
41556	SUPPL	2008-08-08
41555	SUPPL	2008-08-08
41554	SUPPL	2008-08-08
20824	SUPPL	2008-08-08
20823	SUPPL	2008-08-08
20822	SUPPL	2008-08-08
20821	SUPPL	2008-08-08
20820	SUPPL	2008-08-08
41557	SUPPL	2008-08-04
20825	SUPPL	2008-08-04
13208	SUPPL	2003-05-29
3085	SUPPL	2003-05-29
25513	SUPPL	2000-03-20
57464	ORIG	1997-04-11