Application 209406

Type: ANDA
Sponsor: WATSON LABS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BRINZOLAMIDE	BRINZOLAMIDE	SUSPENSION/DROPS;OPHTHALMIC	1%	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
A209406-001	BRINZOLAMIDE	BRINZOLAMIDE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB		2020-11-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209406-001	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.

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	A209406-001	BRINZOLAMIDE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	2020-11-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209406-001	BRINZOLAMIDE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	2020-11-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209406-001	BRINZOLAMIDE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	2020-11-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209406-001	BRINZOLAMIDE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	2020-11-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209406-001	BRINZOLAMIDE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	2020-11-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209406-001	BRINZOLAMIDE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	2020-11-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209406-001	BRINZOLAMIDE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	2020-11-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209406-001	BRINZOLAMIDE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	2020-11-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209406-001	BRINZOLAMIDE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	2020-11-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209406-001	BRINZOLAMIDE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	2020-11-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209406-001	BRINZOLAMIDE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	2020-11-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209406-001	BRINZOLAMIDE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	2020-11-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209406-001	BRINZOLAMIDE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	2020-11-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209406-001	BRINZOLAMIDE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	2020-11-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209406-001	BRINZOLAMIDE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	2020-11-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209406-001	BRINZOLAMIDE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	2020-11-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209406-001	BRINZOLAMIDE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	2020-11-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209406-001	BRINZOLAMIDE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	2020-11-27	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209406-001	BRINZOLAMIDE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	2020-11-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209406-001	BRINZOLAMIDE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	2020-11-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209406-001	BRINZOLAMIDE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	2020-11-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209406-001	BRINZOLAMIDE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	2020-11-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209406-001	BRINZOLAMIDE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	2020-11-27	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209406-001	BRINZOLAMIDE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	2020-11-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209406-001	BRINZOLAMIDE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	2020-11-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209406-001	BRINZOLAMIDE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	2020-11-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209406-001	BRINZOLAMIDE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	2020-11-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209406-001	BRINZOLAMIDE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	2020-11-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209406-001	BRINZOLAMIDE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	2020-11-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209406-001	BRINZOLAMIDE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	2020-11-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209406-001	BRINZOLAMIDE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	2020-11-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209406-001	BRINZOLAMIDE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	2020-11-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209406-001	BRINZOLAMIDE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	2020-11-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209406-001	BRINZOLAMIDE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	2020-11-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209406-001	BRINZOLAMIDE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	2020-11-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209406-001	BRINZOLAMIDE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	2020-11-27	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209406-001	BRINZOLAMIDE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	2020-11-27	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A209406-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209406-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209406-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209406-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209406-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209406-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209406-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209406-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209406-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209406-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209406-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209406-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209406-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209406-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209406-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209406-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209406-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209406-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209406-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209406-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209406-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209406-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209406-001	AB	1	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209406-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209406-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209406-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209406-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209406-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209406-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209406-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209406-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209406-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209406-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209406-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209406-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209406-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209406-001	AB	1	`a50c72e98297…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BRINZOLAMIDE	BRINZOLAMIDE	Oceanside Pharmaceuticals.	fb7229d4-522e-4cb2-b513-9d34f3ded591	2026-04-20	Warnings, Adverse reactions	Name fallback brand name: BRINZOLAMIDE generic name: BRINZOLAMIDE
BRINZOLAMIDE	BRINZOLAMIDE	Padagis US LLC	b56a2e4b-7502-4831-a5b1-0370bdb987b1	2024-08-31	Warnings, Adverse reactions	Name fallback brand name: BRINZOLAMIDE generic name: BRINZOLAMIDE
BRINZOLAMIDE	BRINZOLAMIDE	Bausch & Lomb Incorporated	37b19837-fcab-4536-abad-6f4f92dfe794	2024-07-10	Warnings, Adverse reactions	Name fallback brand name: BRINZOLAMIDE generic name: BRINZOLAMIDE
BRINZOLAMIDE	BRINZOLAMIDE	Bryant Ranch Prepack	460baf5f-1d47-4ae0-b635-84507c3b028d	2023-12-19	Warnings, Adverse reactions	Name fallback brand name: BRINZOLAMIDE generic name: BRINZOLAMIDE
Azopt	BRINZOLAMIDE	Sandoz Inc	0afb6589-51ba-432c-aed1-20a12d5d3455	2023-11-24	Warnings, Adverse reactions	Name fallback generic name: BRINZOLAMIDE
Brinzolamide	BRINZOLAMIDE	Sandoz Inc	ed6dbc25-47d7-42db-9787-5814d71f45ce	2023-06-30	Warnings, Adverse reactions	Name fallback brand name: Brinzolamide generic name: BRINZOLAMIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0591-2127	Brinzolamide	Brinzolamide	Actavis Pharma, Inc.	ANDA	Current
0591-2127	Brinzolamide	Brinzolamide	Actavis Pharma, Inc.	ANDA	Current
0591-2127	Brinzolamide	Brinzolamide	Actavis Pharma, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
65853	ORIG	2021-01-07