Application 202667

Type: NDA
Sponsor: OAK PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	COSOPT PF	DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE	SOLUTION/DROPS;OPHTHALMIC	EQ 2% BASE;EQ 0.5% BASE	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N202667-001	COSOPT PF	DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2012-02-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N202667-001	AT2

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 · 41 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
2026-02-19 14:30 UTC	2026-02	N202667-001	COSOPT PF	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2012-02-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202667-001	COSOPT PF	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2012-02-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202667-001	COSOPT PF	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2012-02-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202667-001	COSOPT PF	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2012-02-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202667-001	COSOPT PF	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2012-02-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202667-001	COSOPT PF	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2012-02-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202667-001	COSOPT PF	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2012-02-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202667-001	COSOPT PF	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2012-02-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202667-001	COSOPT PF	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2012-02-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202667-001	COSOPT PF	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2012-02-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202667-001	COSOPT PF	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2012-02-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202667-001	COSOPT PF	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2012-02-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202667-001	COSOPT PF	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2012-02-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202667-001	COSOPT PF	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2012-02-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202667-001	COSOPT PF	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2012-02-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N202667-001	COSOPT PF	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2012-02-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N202667-001	COSOPT PF	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2012-02-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N202667-001	COSOPT PF	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2012-02-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N202667-001	COSOPT PF	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2012-02-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N202667-001	COSOPT PF	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2012-02-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N202667-001	COSOPT PF	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2012-02-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N202667-001	COSOPT PF	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2012-02-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N202667-001	COSOPT PF	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2012-02-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N202667-001	COSOPT PF	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2012-02-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N202667-001	COSOPT PF	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2012-02-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N202667-001	COSOPT PF	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2012-02-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N202667-001	COSOPT PF	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2012-02-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N202667-001	COSOPT PF	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2012-02-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N202667-001	COSOPT PF	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2012-02-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N202667-001	COSOPT PF	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2012-02-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N202667-001	COSOPT PF	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2012-02-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N202667-001	COSOPT PF	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2012-02-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N202667-001	COSOPT PF	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2012-02-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N202667-001	COSOPT PF	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2012-02-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N202667-001	COSOPT PF	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2012-02-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N202667-001	COSOPT PF	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2012-02-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N202667-001	COSOPT PF	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2012-02-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N202667-001	COSOPT PF	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2012-02-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N202667-001	COSOPT PF	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2012-02-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N202667-001	COSOPT PF	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2012-02-01	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N202667-001	AT2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202667-001	AT2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202667-001	AT2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202667-001	AT2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202667-001	AT2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202667-001	AT2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202667-001	AT2	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202667-001	AT2	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202667-001	AT2	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202667-001	AT2	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202667-001	AT2	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202667-001	AT2	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202667-001	AT2	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202667-001	AT2	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202667-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N202667-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N202667-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N202667-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N202667-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N202667-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N202667-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N202667-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N202667-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N202667-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N202667-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N202667-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N202667-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N202667-001	AT2	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N202667-001	AT2	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N202667-001	AT2	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N202667-001	AT2	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N202667-001	AT2	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N202667-001	AT2	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N202667-001	AT2	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N202667-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N202667-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N202667-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N202667-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N202667-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N202667-001	AT	1	`cb3db0bc1861…`

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
COSOPT PF	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	Thea Pharma Inc.	535fc801-8c3f-4974-a120-3eff1d5a5062	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 202667 application number: NDA202667 ndc (product): 82584-604
Dorzolamide Hydrochloride and Timolol Maleate	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	Akorn	4e90c721-21e8-46ea-ab49-19f535bf7202	2025-09-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 202667 application number: NDA202667 ndc (product): 50383-261

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
17478-604	COSOPT PF	Dorzolamide Hydrochloride and Timolol Maleate	Akorn, Inc.	NDA	Current
17478-604	COSOPT PF	Dorzolamide Hydrochloride and Timolol Maleate	Akorn, Inc.	NDA	Current
17478-604	COSOPT PF	Dorzolamide Hydrochloride and Timolol Maleate	Akorn, Inc.	NDA	Current
17478-604	COSOPT PF	Dorzolamide Hydrochloride and Timolol Maleate	Akorn	NDA	Current
50383-261	Dorzolamide Hydrochloride and Timolol Maleate	Dorzolamide Hydrochloride and Timolol Maleate	Hi-Tech Pharmacal Co., Inc.	NDA	Current
50383-261	Dorzolamide Hydrochloride and Timolol Maleate	Dorzolamide Hydrochloride and Timolol Maleate	Akorn	NDA	Current
50383-261	Dorzolamide Hydrochloride and Timolol Maleate	Dorzolamide Hydrochloride and Timolol Maleate	Hi-Tech Pharmacal Co., Inc.	NDA	Current
50383-261	Dorzolamide Hydrochloride and Timolol Maleate	Dorzolamide Hydrochloride and Timolol Maleate	Hi-Tech Pharmacal Co., Inc.	NDA	Current
82584-604	COSOPT PF	dorzolamide hydrochloride and timolol maleate	Thea Pharma Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85679	SUPPL	2026-04-14
85676	SUPPL	2026-04-14
85674	SUPPL	2026-04-10
24420	ORIG	2012-11-13
22894	ORIG	2012-11-13
19366	ORIG	2012-02-06
10092	ORIG	2012-02-03