Application 021545

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PATADAY ONCE DAILY RELIEF	OLOPATADINE HYDROCHLORIDE	SOLUTION/DROPS;OPHTHALMIC	EQ 0.2% 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
N021545-001	PATADAY ONCE DAILY RELIEF	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22

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	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021545-001	PATADAY	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2004-12-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021545-001	PATADAY	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2004-12-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021545-001	PATADAY	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2004-12-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021545-001	PATADAY	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2004-12-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`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	N021545-001	AT	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N021545-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021545-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021545-001	AT	1	`ea99ee380514…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021545-001	7402609	2022-06-19		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021545-001	7402609*PED	2022-12-19		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021545-001	6995186	2023-11-12	U-765	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021545-001	6995186*PED	2024-05-12		Pediatric extension	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N021545-001	7402609	2022-06-19		Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021545-001	7402609*PED	2022-12-19		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021545-001	6995186	2023-11-12	U-765	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021545-001	6995186*PED	2024-05-12		Pediatric extension	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021545-001	7402609	2022-06-19		Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021545-001	7402609*PED	2022-12-19		Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021545-001	6995186	2023-11-12	U-765	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021545-001	6995186*PED	2024-05-12		Pediatric extension	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021545-001	7402609	2022-06-19		Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021545-001	7402609*PED	2022-12-19		Pediatric extension	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021545-001	6995186	2023-11-12	U-765	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021545-001	6995186*PED	2024-05-12		Pediatric extension	`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 ONCE DAILY RELIEF	OLOPATADINE HYDROCHLORIDE	Alcon Laboratories, Inc.	1c7d2342-ba1c-4244-9814-d92a05725d4e	2026-01-20	Warnings	Exact identifier application applno (NDA): 021545 application number: NDA021545 ndc (product): 0065-8150

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
0065-0272	PATADAY	olopatadine hydrochloride	Alcon Laboratories, Inc.	NDA	Current
0065-0272	PATADAY	olopatadine hydrochloride	Alcon Laboratories, Inc.	NDA	Current
0065-0272	PATADAY	olopatadine hydrochloride	Alcon Laboratories, Inc.	NDA	Current
0065-8150	PATADAY ONCE DAILY RELIEF	OLOPATADINE HYDROCHLORIDE	Alcon Laboratories, Inc.	NDA	Current
0065-8150	PATADAY ONCE DAILY RELIEF	OLOPATADINE HYDROCHLORIDE	Alcon Laboratories, Inc.	NDA	Current
0065-8150	PATADAY ONCE DAILY RELIEF	OLOPATADINE HYDROCHLORIDE	Alcon Laboratories, Inc.	NDA	Current
0065-8150	PATADAY ONCE DAILY RELIEF	OLOPATADINE HYDROCHLORIDE	Alcon Laboratories, Inc.	NDA	Current
0065-8150	PATADAY ONCE DAILY RELIEF	OLOPATADINE HYDROCHLORIDE	Alcon Laboratories, Inc.	NDA	Current
61314-272	Olopatadine Hydrochloride	Olopatadine Hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
61314-272	Olopatadine Hydrochloride	Olopatadine Hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
61314-272	Olopatadine Hydrochloride	Olopatadine Hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82101	SUPPL	2025-05-01
81936	SUPPL	2025-04-21
70718	SUPPL	2022-04-07
68283	SUPPL	2021-08-04
64783	SUPPL	2020-10-01
61900	SUPPL	2020-02-14
61899	SUPPL	2020-02-14
28080	SUPPL	2010-12-10
37196	SUPPL	2010-12-08
5692	SUPPL	2007-06-14
5691	SUPPL	2007-06-14
37195	SUPPL	2007-06-12
37194	SUPPL	2007-06-12
28079	SUPPL	2007-05-01
15739	SUPPL	2007-05-01
21728	ORIG	2007-02-20
15738	ORIG	2004-12-29
5690	ORIG	2004-12-29