Application 021398

Type: NDA
Sponsor: ALLERGAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	COMBIGAN	BRIMONIDINE TARTRATE; TIMOLOL MALEATE	SOLUTION/DROPS;OPHTHALMIC	0.2%;EQ 0.5% BASE	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N021398-001	COMBIGAN	BRIMONIDINE TARTRATE; TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2007-10-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021398-001	AB

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 2 of 2 · 44 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
2022-10-28 04:53 UTC	2022-10	N021398-001	COMBIGAN	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2007-10-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021398-001	COMBIGAN	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2007-10-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021398-001	COMBIGAN	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2007-10-30	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021398-001	COMBIGAN	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2007-10-30	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N021398-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N021398-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021398-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021398-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021398-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021398-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021398-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021398-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021398-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021398-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021398-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021398-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021398-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021398-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021398-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021398-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021398-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021398-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021398-001	AB	1	`5d02ea3f76ae…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021398-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021398-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021398-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021398-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021398-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021398-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021398-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021398-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021398-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021398-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021398-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021398-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021398-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021398-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 188 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	N021398-001	7030149	2022-04-19	U-849			`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021398-001	7320976	2022-04-19	U-849			`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021398-001	7642258	2022-04-19	U-1024	Drug substance, Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021398-001	8133890	2022-04-19	U-1235		2012-04-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021398-001	8354409	2022-04-19	U-1371	Drug product	2013-03-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021398-001	8748425	2022-04-19	U-1524	Drug product	2014-07-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021398-001	9474751	2022-04-19	U-1524	Drug product	2016-10-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021398-001	9770453	2022-04-19	U-2131	Drug product	2017-10-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021398-001	9907801	2022-04-19	U-2239	Drug product	2018-03-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021398-001	9907802	2022-04-19	U-2240	Drug product	2018-03-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021398-001	7030149	2022-04-19	U-849			`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021398-001	7320976	2022-04-19	U-849			`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021398-001	7642258	2022-04-19	U-1024	Drug substance, Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021398-001	8133890	2022-04-19	U-1235		2012-04-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021398-001	8354409	2022-04-19	U-1371	Drug product	2013-03-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021398-001	8748425	2022-04-19	U-1524	Drug product	2014-07-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021398-001	9474751	2022-04-19	U-1524	Drug product	2016-10-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021398-001	9770453	2022-04-19	U-2131	Drug product	2017-10-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021398-001	9907801	2022-04-19	U-2239	Drug product	2018-03-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021398-001	9907802	2022-04-19	U-2240	Drug product	2018-03-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021398-001	7323463	2023-01-19		Drug product, Delist requested		`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021398-001	7030149	2022-04-19	U-849			`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021398-001	7320976	2022-04-19	U-849			`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021398-001	7642258	2022-04-19	U-1024	Drug substance, Drug product		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021398-001	8133890	2022-04-19	U-1235		2012-04-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021398-001	8354409	2022-04-19	U-1371	Drug product	2013-03-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021398-001	8748425	2022-04-19	U-1524	Drug product	2014-07-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021398-001	9474751	2022-04-19	U-1524	Drug product	2016-10-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021398-001	9770453	2022-04-19	U-2131	Drug product	2017-10-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021398-001	9907801	2022-04-19	U-2239	Drug product	2018-03-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021398-001	9907802	2022-04-19	U-2240	Drug product	2018-03-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021398-001	7323463	2023-01-19		Drug product, Delist requested		`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021398-001	7030149	2022-04-19	U-849			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021398-001	7320976	2022-04-19	U-849			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021398-001	7642258	2022-04-19	U-1024	Drug substance, Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021398-001	8133890	2022-04-19	U-1235		2012-04-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021398-001	8354409	2022-04-19	U-1371	Drug product	2013-03-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021398-001	8748425	2022-04-19	U-1524	Drug product	2014-07-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021398-001	9474751	2022-04-19	U-1524	Drug product	2016-10-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021398-001	9770453	2022-04-19	U-2131	Drug product	2017-10-12	`74a2ff9319b5…`

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
COMBIGAN	BRIMONIDINE TARTRATE, TIMOLOL MALEATE	Allergan, Inc.	feaf1480-a4b8-4486-992a-96be3a596243	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021398 application number: NDA021398 ndc (product): 0023-9211

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 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0023-9211	COMBIGAN	brimonidine tartrate, timolol maleate	Allergan, Inc.	NDA	Current
0023-9211	COMBIGAN	brimonidine tartrate, timolol maleate	Allergan, Inc.	NDA	Current
0023-9211	COMBIGAN	brimonidine tartrate, timolol maleate	Allergan, Inc.	NDA	Current
0023-9211	COMBIGAN	brimonidine tartrate, timolol maleate	Allergan, Inc.	NDA	Current
0023-9211	COMBIGAN	brimonidine tartrate, timolol maleate	Allergan, Inc.	NDA	Current
0023-9211	COMBIGAN	brimonidine tartrate, timolol maleate	Allergan, Inc.	NDA	Current
60505-6225	Brimonidine Tartrate/Timolol Maleate	brimonidine tartrate, timolol maleate	Apotex Corp	NDA AUTHORIZED GENERIC	Current
60505-6225	Brimonidine Tartrate/Timolol Maleate	brimonidine tartrate, timolol maleate	Apotex Corp	NDA	Current
82182-455	BRIMONIDINE TARTRATE and TIMOLOL MALEATE	BRIMONIDINE TARTRATE, TIMOLOL MALEATE	Pacific Pharma, Inc.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85471	SUPPL	2026-03-24
85394	SUPPL	2026-03-19
36817	SUPPL	2015-10-22
27666	SUPPL	2015-10-16
5249	SUPPL	2012-10-15
15361	SUPPL	2012-10-12
24196	ORIG	2008-07-22
42137	ORIG	2008-04-22
27665	ORIG	2007-11-08
53203	ORIG	1900-01-01
53202	ORIG	1900-01-01
53201	ORIG	1900-01-01