Application 091691

Type: ANDA
Sponsor: INDOCO REMEDIES

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
A091691-001	BRIMONIDINE TARTRATE	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT		2014-11-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091691-001	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	A091691-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2014-11-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091691-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2014-11-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091691-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2014-11-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091691-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2014-11-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091691-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2014-11-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091691-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2014-11-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091691-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2014-11-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091691-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2014-11-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091691-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2014-11-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091691-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2014-11-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091691-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2014-11-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091691-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2014-11-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091691-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2014-11-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091691-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2014-11-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091691-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2014-11-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091691-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2014-11-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091691-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2014-11-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091691-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2014-11-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091691-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2014-11-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091691-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2014-11-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091691-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2014-11-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091691-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2014-11-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091691-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2014-11-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091691-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2014-11-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091691-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2014-11-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091691-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2014-11-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091691-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2014-11-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091691-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2014-11-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091691-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2014-11-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091691-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2014-11-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091691-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2014-11-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091691-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2014-11-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091691-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2014-11-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091691-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2014-11-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091691-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2014-11-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091691-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2014-11-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091691-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2014-11-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091691-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2014-11-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091691-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2014-11-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091691-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2014-11-18	`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	A091691-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091691-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091691-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091691-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091691-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091691-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091691-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091691-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091691-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091691-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091691-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091691-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091691-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091691-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091691-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091691-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091691-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091691-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091691-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091691-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091691-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091691-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091691-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091691-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091691-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091691-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091691-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091691-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091691-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091691-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091691-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091691-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091691-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091691-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091691-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091691-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091691-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091691-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091691-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091691-001	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Brimonidine Tartrate	BRIMONIDINE TARTRATE	Florida Pharmaceutical Products, LLC	a25f7abf-e066-4d16-a0ba-6150bdace81d	2026-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091691 application number: ANDA091691 ndc (product): 71921-185
Brimonidine Tartrate	BRIMONIDINE TARTRATE	Indoco Remedies Limited	383421a5-5d33-4f15-88f4-8b66fcbfac71	2018-12-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091691 application number: ANDA091691 ndc (product): 14445-400

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
14445-400	Brimonidine Tartrate	Brimonidine Tartrate	Indoco Remedies Limited	ANDA	Current
42843-501	Brimonidine Tartrate	Brimonidine Tartrate	Osmotica Pharmaceutical Corp.	ANDA	Current
71921-185	Brimonidine Tartrate	Brimonidine Tartrate	Florida Pharmaceutical Products, LLC	ANDA	Current
71921-185	Brimonidine Tartrate	Brimonidine Tartrate	Florida Pharmaceutical Products, LLC	ANDA	Current