Application 076439

Type: ANDA
Sponsor: AKORN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BRIMONIDINE TARTRATE	BRIMONIDINE TARTRATE	SOLUTION/DROPS;OPHTHALMIC	0.2%	No	No

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
A076439-001	BRIMONIDINE TARTRATE	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT		2006-03-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076439-001	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A076439-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2006-03-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076439-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2006-03-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076439-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2006-03-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076439-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2006-03-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076439-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2006-03-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076439-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2006-03-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076439-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2006-03-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076439-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2006-03-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076439-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2006-03-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076439-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2006-03-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076439-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2006-03-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076439-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2006-03-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076439-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2006-03-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076439-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2006-03-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076439-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2006-03-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076439-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2006-03-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076439-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2006-03-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076439-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2006-03-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076439-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2006-03-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076439-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2006-03-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076439-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2006-03-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076439-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2006-03-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076439-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2006-03-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076439-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2006-03-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076439-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2006-03-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076439-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2006-03-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076439-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2006-03-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076439-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2006-03-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076439-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2006-03-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076439-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2006-03-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076439-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2006-03-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076439-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2006-03-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076439-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2006-03-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076439-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2006-03-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076439-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2006-03-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076439-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2006-03-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076439-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2006-03-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076439-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2006-03-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076439-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2006-03-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076439-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2006-03-14	`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	A076439-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076439-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076439-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076439-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076439-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076439-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076439-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076439-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076439-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076439-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076439-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076439-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076439-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076439-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076439-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076439-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076439-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076439-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076439-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076439-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076439-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076439-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076439-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076439-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076439-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076439-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076439-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076439-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076439-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076439-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076439-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076439-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076439-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076439-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076439-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076439-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076439-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076439-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076439-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076439-001	AT	1	`e64feba35796…`

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 · 20 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
brimonidine tartrate	BRIMONIDINE TARTRATE	Micro Labs Limited	981a75cd-2487-40e4-911a-26de2aa98dc1	2026-05-21	Warnings, Adverse reactions	Name fallback brand name: brimonidine tartrate generic name: BRIMONIDINE TARTRATE
LUMIFY Redness Reliever Eye Drops	BRIMONIDINE TARTRATE	Bausch & Lomb Incorporated	022de945-0b26-40ae-8e88-d3fe2464d106	2026-03-31	Warnings	Name fallback generic name: BRIMONIDINE TARTRATE
LUMIFY PRESERVATIVE FREE EYE DROPS	BRIMONIDINE TARTRATE	Bausch & Lomb Incorporated	ef5974b9-946c-4983-80e3-32b3aa28c207	2026-03-17	Warnings	Name fallback generic name: BRIMONIDINE TARTRATE
Brimonidine Tartrate	BRIMONIDINE TARTRATE	Gland Pharma Limited	e4b04ef1-6586-4386-a844-2c5fc3bd4a8f	2026-03-12	Warnings, Adverse reactions	Name fallback brand name: Brimonidine Tartrate generic name: BRIMONIDINE TARTRATE
Brimonidine Tartrate	BRIMONIDINE TARTRATE	Florida Pharmaceutical Products, LLC	a25f7abf-e066-4d16-a0ba-6150bdace81d	2026-01-28	Warnings, Adverse reactions	Name fallback brand name: Brimonidine Tartrate generic name: BRIMONIDINE TARTRATE
Brimonidine Tartrate	BRIMONIDINE TARTRATE	Sandoz Inc	b1e7ebd4-d0d2-40a5-aa11-5f68bc5972bd	2025-11-24	Warnings, Adverse reactions	Name fallback brand name: Brimonidine Tartrate generic name: BRIMONIDINE TARTRATE
Brimonidine Tartrate	BRIMONIDINE TARTRATE	Apotex Corp.	64b21e68-610c-5194-ccb2-9d9f6ff8cda9	2025-10-08	Warnings, Adverse reactions	Name fallback brand name: Brimonidine Tartrate generic name: BRIMONIDINE TARTRATE
Brimonidine	BRIMONIDINE TARTRATE	Sandoz Inc	87c5a534-4321-46c7-9938-84dca34b6506	2025-10-07	Warnings, Adverse reactions	Name fallback generic name: BRIMONIDINE TARTRATE
Brimonidine Tartrate	BRIMONIDINE TARTRATE	Apotex Corp.	e08a915a-77ca-4d16-d760-11b05848418d	2025-09-25	Warnings, Adverse reactions	Name fallback brand name: Brimonidine Tartrate generic name: BRIMONIDINE TARTRATE
Brimonidine tartrate	BRIMONIDINE TARTRATE	Pacific Pharma, Inc.	5c4aea88-95ca-4da8-a3da-02f10c8b6623	2025-09-18	Warnings, Adverse reactions	Name fallback brand name: Brimonidine tartrate generic name: BRIMONIDINE TARTRATE
ALPHAGAN P	BRIMONIDINE TARTRATE	Allergan, Inc.	264c4494-c225-486f-888a-caaf36be46b3	2025-09-18	Warnings, Adverse reactions	Name fallback generic name: BRIMONIDINE TARTRATE
Brimonidine tartrate	BRIMONIDINE TARTRATE	Micro Labs Limited	75c5f708-1afb-4505-94a6-a2c0afb0aedc	2025-07-24	Warnings, Adverse reactions	Name fallback brand name: Brimonidine tartrate generic name: BRIMONIDINE TARTRATE
Brimonidine Tartrate	BRIMONIDINE TARTRATE	Sandoz Inc	dfd85672-fa4b-40e3-ac9c-81b8d9e4ffde	2025-05-30	Warnings, Adverse reactions	Name fallback brand name: Brimonidine Tartrate generic name: BRIMONIDINE TARTRATE
BRIMONIDINE TARTRATE	BRIMONIDINE TARTRATE	Somerset Therapeutics, LLC	cdb8620f-adfa-4433-b285-9c42334f8600	2025-03-22	Warnings, Adverse reactions	Name fallback brand name: BRIMONIDINE TARTRATE generic name: BRIMONIDINE TARTRATE
Mirvaso	BRIMONIDINE TARTRATE	Galderma Laboratories, L.P.	f6a4353f-ae69-4214-901f-e5d42a6fbde7	2024-10-24	Warnings, Adverse reactions	Name fallback generic name: BRIMONIDINE TARTRATE
BRIMONIDINE TARTRATE	BRIMONIDINE TARTRATE	Somerset Therapeutics, LLC	b8e108b3-aca8-4e3e-8577-37ac796148c3	2024-08-26	Warnings, Adverse reactions	Name fallback brand name: BRIMONIDINE TARTRATE generic name: BRIMONIDINE TARTRATE
Brimonidine Tartrate	BRIMONIDINE TARTRATE	Bausch & Lomb Incorporated	865f88b0-b13e-4607-a314-939f1b331e6f	2024-07-19	Warnings, Adverse reactions	Name fallback brand name: Brimonidine Tartrate generic name: BRIMONIDINE TARTRATE
Brimonidine Tartrate	BRIMONIDINE TARTRATE	Alembic Pharmaceuticals Limited	ee26e0c9-a169-4842-ab0f-3c718bb14018	2023-08-28	Warnings, Adverse reactions	Name fallback brand name: Brimonidine Tartrate generic name: BRIMONIDINE TARTRATE
Brimonidine Tartrate	BRIMONIDINE TARTRATE	Alembic Pharmaceuticals Inc.	9da815fb-6454-4925-9150-bec40eff9c2d	2023-08-11	Warnings, Adverse reactions	Name fallback brand name: Brimonidine Tartrate generic name: BRIMONIDINE TARTRATE
Brimonidine Tartrate	BRIMONIDINE TARTRATE	Indoco Remedies Limited	383421a5-5d33-4f15-88f4-8b66fcbfac71	2018-12-27	Warnings, Adverse reactions	Name fallback brand name: Brimonidine Tartrate generic name: BRIMONIDINE TARTRATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
17478-715	Brimonidine	Brimonidine Tartrate	Akorn, Inc.	ANDA	Current
17478-715	Brimonidine	Brimonidine Tartrate	Akorn	ANDA	Current
17478-715	Brimonidine	Brimonidine Tartrate	Akorn, Inc.	ANDA	Current
17478-715	Brimonidine	Brimonidine Tartrate	Akorn	ANDA	Current
25685-715	Brimonidine Tartrate	brimonidine tartrate	Regimed Medical	ANDA	Current
50090-1046	Brimonidine	Brimonidine Tartrate	A-S Medication Solutions	ANDA	Current