Application 021262

Type: NDA
Sponsor: ALLERGAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ALPHAGAN P	BRIMONIDINE TARTRATE	SOLUTION/DROPS;OPHTHALMIC	0.15%	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
N021262-001	ALPHAGAN P	BRIMONIDINE TARTRATE	0.15%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2001-03-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N021262-001	AT

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	N021262-001	ALPHAGAN P	0.15%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2001-03-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021262-001	ALPHAGAN P	0.15%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2001-03-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021262-001	ALPHAGAN P	0.15%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2001-03-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021262-001	ALPHAGAN P	0.15%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2001-03-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021262-001	ALPHAGAN P	0.15%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2001-03-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021262-001	ALPHAGAN P	0.15%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2001-03-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021262-001	ALPHAGAN P	0.15%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2001-03-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021262-001	ALPHAGAN P	0.15%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2001-03-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021262-001	ALPHAGAN P	0.15%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2001-03-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021262-001	ALPHAGAN P	0.15%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2001-03-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021262-001	ALPHAGAN P	0.15%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2001-03-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021262-001	ALPHAGAN P	0.15%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2001-03-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021262-001	ALPHAGAN P	0.15%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2001-03-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021262-001	ALPHAGAN P	0.15%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2001-03-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021262-001	ALPHAGAN P	0.15%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2001-03-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021262-001	ALPHAGAN P	0.15%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2001-03-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021262-001	ALPHAGAN P	0.15%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2001-03-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021262-001	ALPHAGAN P	0.15%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2001-03-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021262-001	ALPHAGAN P	0.15%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2001-03-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021262-001	ALPHAGAN P	0.15%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2001-03-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021262-001	ALPHAGAN P	0.15%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2001-03-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021262-001	ALPHAGAN P	0.15%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2001-03-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021262-001	ALPHAGAN P	0.15%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2001-03-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021262-001	ALPHAGAN P	0.15%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2001-03-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021262-001	ALPHAGAN P	0.15%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2001-03-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021262-001	ALPHAGAN P	0.15%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2001-03-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021262-001	ALPHAGAN P	0.15%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2001-03-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021262-001	ALPHAGAN P	0.15%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2001-03-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021262-001	ALPHAGAN P	0.15%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2001-03-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021262-001	ALPHAGAN P	0.15%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2001-03-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021262-001	ALPHAGAN P	0.15%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2001-03-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021262-001	ALPHAGAN P	0.15%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2001-03-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021262-001	ALPHAGAN P	0.15%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2001-03-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021262-001	ALPHAGAN P	0.15%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2001-03-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021262-001	ALPHAGAN P	0.15%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2001-03-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021262-001	ALPHAGAN P	0.15%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2001-03-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021262-001	ALPHAGAN P	0.15%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2001-03-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021262-001	ALPHAGAN P	0.15%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2001-03-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021262-001	ALPHAGAN P	0.15%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2001-03-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021262-001	ALPHAGAN P	0.15%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2001-03-16	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N021262-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021262-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021262-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021262-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021262-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021262-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021262-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021262-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021262-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021262-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021262-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021262-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021262-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021262-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021262-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021262-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021262-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021262-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021262-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021262-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021262-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021262-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021262-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021262-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021262-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021262-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021262-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021262-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021262-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021262-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021262-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021262-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021262-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021262-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021262-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021262-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021262-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021262-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021262-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021262-001	AT	1	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 135 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	N021262-001	6562873*PED	2022-01-10		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021262-001	9295641*PED	2022-01-10		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021262-001	6627210*PED	2022-01-18		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021262-001	6673337*PED	2022-01-26		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021262-001	6641834*PED	2022-01-28		Pediatric extension		`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021262-001	6562873*PED	2022-01-10		Pediatric extension		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021262-001	9295641*PED	2022-01-10		Pediatric extension		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021262-001	6627210*PED	2022-01-18		Pediatric extension		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021262-001	6673337*PED	2022-01-26		Pediatric extension		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021262-001	6641834*PED	2022-01-28		Pediatric extension		`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021262-001	6562873*PED	2022-01-10		Pediatric extension		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021262-001	9295641*PED	2022-01-10		Pediatric extension		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021262-001	6627210*PED	2022-01-18		Pediatric extension		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021262-001	6673337*PED	2022-01-26		Pediatric extension		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021262-001	6641834*PED	2022-01-28		Pediatric extension		`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021262-001	6562873	2021-07-10				`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021262-001	9295641	2021-07-10	U-1833		2016-04-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021262-001	6627210	2021-07-18		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021262-001	6673337	2021-07-26		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021262-001	6641834	2021-07-28		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021262-001	6562873*PED	2022-01-10		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021262-001	9295641*PED	2022-01-10		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021262-001	6627210*PED	2022-01-18		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021262-001	6673337*PED	2022-01-26		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021262-001	6641834*PED	2022-01-28		Pediatric extension		`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021262-001	6562873*PED	2022-01-10		Pediatric extension		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021262-001	9295641*PED	2022-01-10		Pediatric extension		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021262-001	6627210*PED	2022-01-18		Pediatric extension		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021262-001	6673337*PED	2022-01-26		Pediatric extension		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021262-001	6641834*PED	2022-01-28		Pediatric extension		`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021262-001	6562873	2021-07-10				`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021262-001	9295641	2021-07-10	U-1833		2016-04-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021262-001	6627210	2021-07-18		Drug product		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021262-001	6673337	2021-07-26		Drug product		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021262-001	6641834	2021-07-28		Drug product		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021262-001	6562873*PED	2022-01-10		Pediatric extension		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021262-001	9295641*PED	2022-01-10		Pediatric extension		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021262-001	6627210*PED	2022-01-18		Pediatric extension		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021262-001	6673337*PED	2022-01-26		Pediatric extension		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021262-001	6641834*PED	2022-01-28		Pediatric extension		`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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Brimonidine tartrate	BRIMONIDINE TARTRATE	Pacific Pharma, Inc.	5c4aea88-95ca-4da8-a3da-02f10c8b6623	2025-09-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021262 application number: NDA021262 ndc (product): 82182-773
ALPHAGAN P	BRIMONIDINE TARTRATE	Allergan, Inc.	264c4494-c225-486f-888a-caaf36be46b3	2025-09-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021262 application number: NDA021262 ndc (product): 0023-9177

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0023-9177	ALPHAGAN P	brimonidine tartrate	Allergan, Inc.	NDA	Current
0023-9177	ALPHAGAN P	brimonidine tartrate	Allergan, Inc.	NDA	Current
0023-9177	ALPHAGAN P	brimonidine tartrate	Allergan, Inc.	NDA	Current
0023-9177	ALPHAGAN P	brimonidine tartrate	Allergan, Inc.	NDA	Current
82182-773	Brimonidine tartrate	brimonidine tartrate	Pacific Pharma, Inc.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83400	SUPPL	2025-09-19
83393	SUPPL	2025-09-19
14780	SUPPL	2010-08-28
27259	SUPPL	2010-08-16
27258	SUPPL	2006-05-25
14779	SUPPL	2006-05-24
42062	SUPPL	2004-05-27
42061	ORIG	2004-05-27
27257	SUPPL	2004-02-27
4823	SUPPL	2004-02-27
27256	SUPPL	2001-12-20
14778	SUPPL	2001-12-20
36501	ORIG	2001-03-16
27255	ORIG	2001-03-16