Application 020816

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AZOPT	BRINZOLAMIDE	SUSPENSION/DROPS;OPHTHALMIC	1%	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
N020816-001	AZOPT	BRINZOLAMIDE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020816-001	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 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	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC		RLD, RS	1998-04-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC		RLD, RS	1998-04-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC		RLD, RS	1998-04-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC		RLD, RS	1998-04-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC		RLD, RS	1998-04-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`e64feba35796…`

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	N020816-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020816-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020816-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020816-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020816-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020816-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020816-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020816-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020816-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020816-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020816-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020816-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020816-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020816-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020816-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020816-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020816-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020816-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N020816-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020816-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020816-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020816-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020816-001	AB	1	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020816-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020816-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020816-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020816-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020816-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020816-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020816-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020816-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020816-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020816-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020816-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020816-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020816-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N020816-001	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Azopt	BRINZOLAMIDE	Sandoz Inc	0afb6589-51ba-432c-aed1-20a12d5d3455	2023-11-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020816 application number: NDA020816
Brinzolamide	BRINZOLAMIDE	Sandoz Inc	ed6dbc25-47d7-42db-9787-5814d71f45ce	2023-06-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020816 application number: NDA020816 ndc (product): 0781-6014

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0065-0275	Azopt	brinzolamide	Alcon Laboratories, Inc.	NDA	Current
0065-0275	Azopt	brinzolamide	Alcon Laboratories, Inc.	NDA	Current
0065-0275	Azopt	brinzolamide	Alcon Laboratories, Inc.	NDA	Current
0065-0275	Azopt	brinzolamide	Alcon Laboratories, Inc.	NDA	Current
0065-0275	Azopt	brinzolamide	Alcon Laboratories, Inc.	NDA	Current
0078-0722	Azopt	brinzolamide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0722	Azopt	brinzolamide	Novartis Pharmaceuticals Corporation	NDA	Current
0781-6014	Brinzolamide	Brinzolamide	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-6014	Brinzolamide	Brinzolamide	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
63629-8793	Brinzolamide	Brinzolamide	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-8793	Brinzolamide	Brinzolamide	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74685	SUPPL	2023-07-03
74658	SUPPL	2023-06-29
67906	SUPPL	2021-06-28
67889	SUPPL	2021-06-24
25892	SUPPL	2015-11-13
13472	SUPPL	2015-11-12
35400	SUPPL	2011-03-11
25891	SUPPL	2011-03-10
25890	SUPPL	2006-10-02
35399	SUPPL	2003-07-28
3408	SUPPL	2003-07-28
20974	ORIG	2003-06-19
35398	ORIG	1998-04-01
25889	ORIG	1998-04-01
51788	ORIG	1900-01-01
51787	ORIG	1900-01-01