Application 206276

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PAZEO	OLOPATADINE HYDROCHLORIDE	SOLUTION/DROPS;OPHTHALMIC	EQ 0.7% BASE	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N206276-001	PATADAY ONCE DAILY RELIEF	OLOPATADINE HYDROCHLORIDE	EQ 0.7% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2015-01-30

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N206276-001	8791154	2032-05-19	U-1680	Drug product	2015-03-31
N206276-001	9533053	2032-05-19		Drug product	2020-08-31

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N206276-001	PATADAY ONCE DAILY RELIEF	EQ 0.7% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2015-01-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206276-001	PATADAY ONCE DAILY RELIEF	EQ 0.7% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2015-01-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206276-001	PATADAY ONCE DAILY RELIEF	EQ 0.7% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2015-01-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206276-001	PATADAY ONCE DAILY RELIEF	EQ 0.7% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2015-01-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206276-001	PATADAY ONCE DAILY RELIEF	EQ 0.7% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2015-01-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206276-001	PATADAY ONCE DAILY RELIEF	EQ 0.7% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2015-01-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206276-001	PATADAY ONCE DAILY RELIEF	EQ 0.7% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2015-01-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206276-001	PATADAY ONCE DAILY RELIEF	EQ 0.7% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2015-01-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206276-001	PATADAY ONCE DAILY RELIEF	EQ 0.7% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2015-01-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206276-001	PATADAY ONCE DAILY RELIEF	EQ 0.7% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2015-01-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206276-001	PATADAY ONCE DAILY RELIEF	EQ 0.7% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2015-01-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206276-001	PATADAY ONCE DAILY RELIEF	EQ 0.7% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2015-01-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206276-001	PATADAY ONCE DAILY RELIEF	EQ 0.7% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2015-01-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N206276-001	PATADAY ONCE DAILY RELIEF	EQ 0.7% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2015-01-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206276-001	PATADAY ONCE DAILY RELIEF	EQ 0.7% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2015-01-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N206276-001	PATADAY ONCE DAILY RELIEF	EQ 0.7% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2015-01-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N206276-001	PATADAY ONCE DAILY RELIEF	EQ 0.7% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2015-01-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N206276-001	PAZEO	EQ 0.7% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2015-01-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N206276-001	PATADAY ONCE DAILY RELIEF	EQ 0.7% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2015-01-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N206276-001	PATADAY ONCE DAILY RELIEF	EQ 0.7% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2015-01-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N206276-001	PATADAY ONCE DAILY RELIEF	EQ 0.7% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2015-01-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N206276-001	PATADAY ONCE DAILY RELIEF	EQ 0.7% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2015-01-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N206276-001	PATADAY ONCE DAILY RELIEF	EQ 0.7% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2015-01-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N206276-001	PATADAY ONCE DAILY RELIEF	EQ 0.7% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2015-01-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N206276-001	PAZEO	EQ 0.7% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2015-01-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N206276-001	PAZEO	EQ 0.7% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2015-01-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N206276-001	PAZEO	EQ 0.7% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2015-01-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N206276-001	PATADAY ONCE DAILY RELIEF	EQ 0.7% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2015-01-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N206276-001	PATADAY ONCE DAILY RELIEF	EQ 0.7% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2015-01-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N206276-001	PATADAY ONCE DAILY RELIEF	EQ 0.7% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2015-01-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N206276-001	PATADAY ONCE DAILY RELIEF	EQ 0.7% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2015-01-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N206276-001	PATADAY ONCE DAILY RELIEF	EQ 0.7% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2015-01-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N206276-001	PATADAY ONCE DAILY RELIEF	EQ 0.7% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2015-01-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N206276-001	PATADAY ONCE DAILY RELIEF	EQ 0.7% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2015-01-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N206276-001	PATADAY ONCE DAILY RELIEF	EQ 0.7% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2015-01-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N206276-001	PATADAY ONCE DAILY RELIEF	EQ 0.7% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2015-01-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N206276-001	PATADAY ONCE DAILY RELIEF	EQ 0.7% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2015-01-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N206276-001	PATADAY ONCE DAILY RELIEF	EQ 0.7% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2015-01-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N206276-001	PATADAY ONCE DAILY RELIEF	EQ 0.7% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2015-01-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N206276-001	PATADAY ONCE DAILY RELIEF	EQ 0.7% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2015-01-30	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N206276-001	8791154	2032-05-19	U-1680	Drug product	2015-03-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206276-001	9533053	2032-05-19		Drug product	2020-08-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206276-001	8791154	2032-05-19	U-1680	Drug product	2015-03-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206276-001	9533053	2032-05-19		Drug product	2020-08-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206276-001	8791154	2032-05-19	U-1680	Drug product	2015-03-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206276-001	9533053	2032-05-19		Drug product	2020-08-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206276-001	8791154	2032-05-19	U-1680	Drug product	2015-03-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206276-001	9533053	2032-05-19		Drug product	2020-08-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206276-001	8791154	2032-05-19	U-1680	Drug product	2015-03-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206276-001	9533053	2032-05-19		Drug product	2020-08-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206276-001	8791154	2032-05-19	U-1680	Drug product	2015-03-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206276-001	9533053	2032-05-19		Drug product	2020-08-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206276-001	8791154	2032-05-19	U-1680	Drug product	2015-03-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206276-001	9533053	2032-05-19		Drug product	2020-08-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206276-001	8791154	2032-05-19	U-1680	Drug product	2015-03-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206276-001	9533053	2032-05-19		Drug product	2020-08-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206276-001	8791154	2032-05-19	U-1680	Drug product	2015-03-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206276-001	9533053	2032-05-19		Drug product	2020-08-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206276-001	8791154	2032-05-19	U-1680	Drug product	2015-03-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N206276-001	9533053	2032-05-19		Drug product	2020-08-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206276-001	8791154	2032-05-19	U-1680	Drug product	2015-03-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206276-001	9533053	2032-05-19		Drug product	2020-08-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206276-001	8791154	2032-05-19	U-1680	Drug product	2015-03-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206276-001	9533053	2032-05-19		Drug product	2020-08-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206276-001	8791154	2032-05-19	U-1680	Drug product	2015-03-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206276-001	9533053	2032-05-19		Drug product	2020-08-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N206276-001	8791154	2032-05-19	U-1680	Drug product	2015-03-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N206276-001	9533053	2032-05-19		Drug product	2020-08-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206276-001	8791154	2032-05-19	U-1680	Drug product	2015-03-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206276-001	9533053	2032-05-19		Drug product	2020-08-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N206276-001	8791154	2032-05-19	U-1680	Drug product	2015-03-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N206276-001	9533053	2032-05-19		Drug product	2020-08-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N206276-001	8791154	2032-05-19	U-1680	Drug product	2015-03-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N206276-001	9533053	2032-05-19		Drug product	2020-08-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N206276-001	8791154	2032-05-19	U-1680	Drug product	2015-03-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206276-001	9533053	2032-05-19		Drug product	2017-01-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N206276-001	8791154	2032-05-19	U-1680	Drug product	2015-03-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N206276-001	9533053	2032-05-19		Drug product	2020-08-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N206276-001	8791154	2032-05-19	U-1680	Drug product	2015-03-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N206276-001	9533053	2032-05-19		Drug product	2020-08-31	`782e0a99824c…`

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.	6d07a5d6-265c-4735-97b3-8a2575b276cb	2026-01-20	Warnings	Exact identifier application applno (NDA): 206276 application number: NDA206276 ndc (product): 0065-0816

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0065-0816	PATADAY ONCE DAILY RELIEF	OLOPATADINE HYDROCHLORIDE	Alcon Laboratories, Inc.	NDA	Current
0065-0816	PATADAY ONCE DAILY RELIEF	OLOPATADINE HYDROCHLORIDE	Alcon Laboratories, Inc.	NDA	Current
0065-0816	PATADAY ONCE DAILY RELIEF	OLOPATADINE HYDROCHLORIDE	Alcon Laboratories, Inc.	NDA	Current
0065-0816	PATADAY ONCE DAILY RELIEF	OLOPATADINE HYDROCHLORIDE	Alcon Laboratories, Inc.	NDA	Current
0065-4273	Pazeo	olopatadine hydrochloride	Alcon Laboratories, Inc.	NDA	Current
0065-4273	Pazeo	olopatadine hydrochloride	Alcon Laboratories, Inc.	NDA	Current
0065-4273	Pazeo	olopatadine hydrochloride	Alcon Laboratories, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82102	SUPPL	2025-05-01
81937	SUPPL	2025-04-21
70731	SUPPL	2022-04-07
69809	SUPPL	2022-01-05
63960	SUPPL	2020-07-17
63959	SUPPL	2020-07-17
43511	SUPPL	2016-02-03
23018	ORIG	2015-04-13
19711	ORIG	2015-03-27
10554	ORIG	2015-02-11
51448	ORIG	1900-01-01
51447	ORIG	1900-01-01
51446	ORIG	1900-01-01