Application 201998

Type: ANDA
Sponsor: LANNETT CO INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE	SOLUTION/DROPS;OPHTHALMIC	EQ 2% BASE;EQ 0.5% BASE	No	No

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
A201998-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC			2014-12-17

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A201998-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	2014-12-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201998-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	2014-12-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201998-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	2014-12-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201998-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	2014-12-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201998-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	2014-12-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201998-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	2014-12-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201998-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	2014-12-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201998-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	2014-12-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201998-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	2014-12-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201998-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	2014-12-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201998-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	2014-12-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201998-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	2014-12-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201998-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	2014-12-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201998-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	2014-12-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201998-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	2014-12-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201998-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	2014-12-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201998-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	2014-12-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201998-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	2014-12-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201998-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	2014-12-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201998-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	2014-12-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201998-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	2014-12-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201998-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	2014-12-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201998-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	2014-12-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201998-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	2014-12-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201998-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	2014-12-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201998-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	2014-12-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201998-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	2014-12-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201998-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	2014-12-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201998-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	2014-12-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201998-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	2014-12-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201998-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	2014-12-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201998-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	2014-12-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201998-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	2014-12-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201998-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	2014-12-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201998-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	2014-12-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201998-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	2014-12-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201998-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	2014-12-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201998-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	2014-12-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201998-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	2014-12-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201998-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	2014-12-17	`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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dorzolamide Hydrochloride and Timolol Maleate	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	Bryant Ranch Prepack	ff76c0cf-256c-4015-94f4-405f0c46205f	2026-05-01	Warnings, Adverse reactions	Name fallback brand name: Dorzolamide Hydrochloride and Timolol Maleate
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE PRESERVATIVE FREE	Micro Labs Limited	b0a1d984-efee-4751-9797-c09adc2d307d	2026-04-30	Warnings, Adverse reactions	Name fallback brand name: DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
Dorzolamide Hydrochloride and Timolol Maleate	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	Akorn	4e90c721-21e8-46ea-ab49-19f535bf7202	2025-09-10	Warnings, Adverse reactions	Name fallback brand name: Dorzolamide Hydrochloride and Timolol Maleate
Dorzolamide Hydrochloride and Timolol Maleate	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	Genus Lifesciences	3b3a4716-1082-4a7a-bf5a-2e2bac38dfbc	2025-09-08	Warnings, Adverse reactions	Name fallback brand name: Dorzolamide Hydrochloride and Timolol Maleate
Dorzolamide Hydrochloride and Timolol Maleate	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	A-S Medication Solutions	8cdf22c8-75ca-404e-b354-9e254690d0e7	2024-11-01	Warnings, Adverse reactions	Name fallback brand name: Dorzolamide Hydrochloride and Timolol Maleate
DORZOLAMIDE HYDROCHLORIDE and TIMOLOL MALEATE	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	Somerset Therapeutics, LLC	17f04726-725f-4839-911d-47fc5e02baae	2024-09-18	Warnings, Adverse reactions	Name fallback brand name: DORZOLAMIDE HYDROCHLORIDE and TIMOLOL MALEATE
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE PRESERVATIVE FREE	Bryant Ranch Prepack	cfdc5577-fe7a-4b51-b2f5-95806e1dee2d	2024-08-20	Warnings, Adverse reactions	Name fallback brand name: DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
Dorzolamide Hydrochloride and Timolol Maleate	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	Aurobindo Pharma Limited	2d5dcaa5-97ee-40c3-aa29-fcfb91fb78e1	2024-05-21	Warnings, Adverse reactions	Name fallback brand name: Dorzolamide Hydrochloride and Timolol Maleate
Dorzolamide Hydrochloride and Timolol Maleate	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	Gland Pharma Limited	efab039e-a69d-4306-8305-b1d27781cfe0	2024-05-14	Warnings, Adverse reactions	Name fallback brand name: Dorzolamide Hydrochloride and Timolol Maleate
Dorzolamide Hydrochloride and Timolol Maleate	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	Bryant Ranch Prepack	be8b1a47-3342-4072-b67c-6d1374d5d4d6	2023-12-07	Warnings, Adverse reactions	Name fallback brand name: Dorzolamide Hydrochloride and Timolol Maleate
Dorzolamide hydrochloride and timolol maleate	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	Ingenus Pharmaceuticals, LLC	36c0e765-dfda-4b3b-8a98-a5f8b32607f7	2023-08-02	Warnings, Adverse reactions	Name fallback brand name: Dorzolamide hydrochloride and timolol maleate
Dorzolamide Hydrochloride and Timolol Maleate	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	Bausch & Lomb Incorporated	7f6ab3f6-3644-434c-b6cf-e4f111d18962	2023-06-23	Warnings, Adverse reactions	Name fallback brand name: Dorzolamide Hydrochloride and Timolol Maleate
Dorzolamide Hydrochloride and Timolol Maleate	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	Sandoz Inc	78f39126-3e3b-4633-a4e0-c1f09a794eec	2021-05-31	Warnings, Adverse reactions	Name fallback brand name: Dorzolamide Hydrochloride and Timolol Maleate

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0527-1763	Dorzolamide Hydrochloride-Timolol Maleate	Dorzolamide Hydrochloride-Timolol Maleate	Lannett Company, Inc.	ANDA	Current
0527-1763	Dorzolamide Hydrochloride-Timolol Maleate	Dorzolamide Hydrochloride-Timolol Maleate	Lannett Company, Inc.	ANDA	Current