Application 020408

Type: NDA
Sponsor: MERCK

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRUSOPT	DORZOLAMIDE HYDROCHLORIDE	SOLUTION/DROPS;OPHTHALMIC	EQ 2% BASE	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
N020408-001	TRUSOPT	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	1994-12-09

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	N020408-001	TRUSOPT	EQ 2% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	1994-12-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020408-001	TRUSOPT	EQ 2% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	1994-12-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020408-001	TRUSOPT	EQ 2% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	1994-12-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020408-001	TRUSOPT	EQ 2% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	1994-12-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020408-001	TRUSOPT	EQ 2% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	1994-12-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020408-001	TRUSOPT	EQ 2% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	1994-12-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020408-001	TRUSOPT	EQ 2% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	1994-12-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020408-001	TRUSOPT	EQ 2% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	1994-12-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020408-001	TRUSOPT	EQ 2% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	1994-12-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020408-001	TRUSOPT	EQ 2% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	1994-12-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020408-001	TRUSOPT	EQ 2% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	1994-12-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020408-001	TRUSOPT	EQ 2% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	1994-12-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020408-001	TRUSOPT	EQ 2% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	1994-12-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020408-001	TRUSOPT	EQ 2% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	1994-12-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020408-001	TRUSOPT	EQ 2% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	1994-12-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020408-001	TRUSOPT	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD	1994-12-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020408-001	TRUSOPT	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1994-12-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020408-001	TRUSOPT	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1994-12-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020408-001	TRUSOPT	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1994-12-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020408-001	TRUSOPT	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1994-12-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020408-001	TRUSOPT	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1994-12-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020408-001	TRUSOPT	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1994-12-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020408-001	TRUSOPT	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1994-12-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020408-001	TRUSOPT	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1994-12-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020408-001	TRUSOPT	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1994-12-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020408-001	TRUSOPT	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1994-12-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020408-001	TRUSOPT	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1994-12-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020408-001	TRUSOPT	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1994-12-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020408-001	TRUSOPT	EQ 2% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	1994-12-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020408-001	TRUSOPT	EQ 2% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	1994-12-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020408-001	TRUSOPT	EQ 2% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	1994-12-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020408-001	TRUSOPT	EQ 2% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	1994-12-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020408-001	TRUSOPT	EQ 2% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	1994-12-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020408-001	TRUSOPT	EQ 2% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	1994-12-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020408-001	TRUSOPT	EQ 2% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	1994-12-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020408-001	TRUSOPT	EQ 2% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	1994-12-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020408-001	TRUSOPT	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD	1994-12-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020408-001	TRUSOPT	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD	1994-12-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020408-001	TRUSOPT	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD	1994-12-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020408-001	TRUSOPT	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD	1994-12-09	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-08 23:34 UTC	2022-04	N020408-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020408-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020408-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020408-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020408-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020408-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020408-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020408-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020408-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020408-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020408-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020408-001	AT	1	`ea99ee380514…`

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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dorzolamide Hydrochloride	DORZOLAMIDE HYDROCHLORIDE	Sagent Pharmaceuticals	0246463c-6c24-4611-8e22-2d5254ace66a	2026-01-09	Warnings, Adverse reactions	Name fallback generic name: DORZOLAMIDE HYDROCHLORIDE
Dorzolamide Hydrochloride	DORZOLAMIDE HYDROCHLORIDE	FOSUN PHARMA USA INC	ef173b63-499f-301b-e053-2995a90a4771	2025-09-26	Warnings, Adverse reactions	Name fallback generic name: DORZOLAMIDE HYDROCHLORIDE
Dorzolamide Hydrochloride	DORZOLAMIDE HYDROCHLORIDE	Gland Pharma Limited	2023e603-12bb-4502-9f93-0126e0cc24ed	2025-05-10	Warnings, Adverse reactions	Name fallback generic name: DORZOLAMIDE HYDROCHLORIDE
DORZOLAMIDE HYDROCHLORIDE	DORZOLAMIDE HYDROCHLORIDE	Advagen Pharma Ltd.	ed9d1658-43cc-4c78-b3d8-e7d980a6b673	2025-02-28	Warnings, Adverse reactions	Name fallback generic name: DORZOLAMIDE HYDROCHLORIDE
Dorzolamide Hydrochloride	DORZOLAMIDE HYDROCHLORIDE	Somerset Therapeutics, LLC	0832960f-0a6f-4fd1-bf55-be9bebde53bd	2025-02-12	Warnings, Adverse reactions	Name fallback generic name: DORZOLAMIDE HYDROCHLORIDE
Dorzolamide Hydrochloride Ophthalmic Solution	DORZOLAMIDE HYDROCHLORIDE	Micro Labs Limited	4698e4e1-c5f6-4db1-9328-74464a85afea	2025-01-08	Warnings, Adverse reactions	Name fallback generic name: DORZOLAMIDE HYDROCHLORIDE
Dorzolamide Hydrochloride	DORZOLAMIDE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	5ad43fd4-19f0-448f-97a8-625ada4cb147	2024-08-27	Warnings, Adverse reactions	Name fallback generic name: DORZOLAMIDE HYDROCHLORIDE
Dorzolamide Hydrochloride	DORZOLAMIDE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	fb2e0729-b0bc-4c3f-9961-8bb38f84a032	2024-08-27	Warnings, Adverse reactions	Name fallback generic name: DORZOLAMIDE HYDROCHLORIDE
Dorzolamide hydrochloride	DORZOLAMIDE HYDROCHLORIDE	Leading Pharma, LLC	7d4cb6cd-86d0-41d9-baa9-bca0fa7b0694	2024-05-24	Warnings, Adverse reactions	Name fallback generic name: DORZOLAMIDE HYDROCHLORIDE
Dorzolamide Hydrochloride Ophthalmic	DORZOLAMIDE HYDROCHLORIDE	A-S Medication Solutions	fa4b8802-3271-48a4-8a91-229ebc72f570	2023-12-15	Warnings, Adverse reactions	Name fallback generic name: DORZOLAMIDE HYDROCHLORIDE
DORZOLAMIDE HYDROCHLORIDE	DORZOLAMIDE HYDROCHLORIDE	Sandoz Inc	29157995-fa61-4425-86a5-5bd0e4718cd8	2022-12-20	Warnings, Adverse reactions	Name fallback generic name: DORZOLAMIDE HYDROCHLORIDE

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
0006-3519	TRUSOPT	dorzolamide hydrochloride	Merck Sharp & Dohme Corp.	NDA	Current
0006-3519	TRUSOPT	dorzolamide hydrochloride	Merck Sharp & Dohme Corp.	NDA	Current
0006-3519	TRUSOPT	dorzolamide hydrochloride	Merck Sharp & Dohme LLC	NDA	Current
0006-3519	TRUSOPT	dorzolamide hydrochloride	Merck Sharp & Dohme Corp.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
65764	SUPPL	2020-12-28
65699	SUPPL	2020-12-23
24935	SUPPL	2014-02-10
12554	SUPPL	2014-02-06
12553	SUPPL	2010-06-24
2500	SUPPL	2010-06-22
34624	SUPPL	2008-11-07
24934	SUPPL	2008-10-24
20650	SUPPL	2008-07-31
24933	SUPPL	2006-01-19
34623	SUPPL	2006-01-05
12552	SUPPL	2004-05-03
24932	SUPPL	2004-04-20
12551	SUPPL	2002-04-12
2498	SUPPL	2002-04-12
34622	SUPPL	2002-04-09
2499	SUPPL	2002-04-09
51841	SUPPL	1900-01-01
51840	SUPPL	1900-01-01
51838	SUPPL	1900-01-01
51836	SUPPL	1900-01-01
51834	SUPPL	1900-01-01