Application 078981

Type: ANDA
Sponsor: SANDOZ INC

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A078981-001	DORZOLAMIDE HYDROCHLORIDE	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT		2009-04-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078981-001	AT

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 · 44 observed 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
2026-10-15 13:18:30	2026-09	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A078981-001	AT	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A078981-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078981-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078981-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078981-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078981-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078981-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078981-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078981-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078981-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078981-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078981-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078981-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078981-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078981-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078981-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078981-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078981-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078981-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078981-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078981-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078981-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078981-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078981-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078981-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078981-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078981-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078981-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078981-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078981-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078981-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078981-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078981-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078981-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078981-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078981-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078981-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078981-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078981-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078981-001	AT	1	`3a93d1ddd44b…`

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 brand name: Dorzolamide Hydrochloride 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 brand name: Dorzolamide Hydrochloride generic name: DORZOLAMIDE HYDROCHLORIDE
Dorzolamide Hydrochloride	DORZOLAMIDE HYDROCHLORIDE	Gland Pharma Limited	2023e603-12bb-4502-9f93-0126e0cc24ed	2025-05-10	Warnings, Adverse reactions	Name fallback brand name: Dorzolamide Hydrochloride generic name: DORZOLAMIDE HYDROCHLORIDE
DORZOLAMIDE HYDROCHLORIDE	DORZOLAMIDE HYDROCHLORIDE	Advagen Pharma Ltd.	ed9d1658-43cc-4c78-b3d8-e7d980a6b673	2025-02-28	Warnings, Adverse reactions	Name fallback brand name: DORZOLAMIDE HYDROCHLORIDE generic name: DORZOLAMIDE HYDROCHLORIDE
Dorzolamide Hydrochloride	DORZOLAMIDE HYDROCHLORIDE	Somerset Therapeutics, LLC	0832960f-0a6f-4fd1-bf55-be9bebde53bd	2025-02-12	Warnings, Adverse reactions	Name fallback brand name: Dorzolamide Hydrochloride 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	Indoco Remedies Limited	462a61b2-1ec6-4d18-bc6b-fc03e027caa0	2024-10-04	Warnings, Adverse reactions	Name fallback brand name: Dorzolamide Hydrochloride
Dorzolamide Hydrochloride	DORZOLAMIDE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	5ad43fd4-19f0-448f-97a8-625ada4cb147	2024-08-27	Warnings, Adverse reactions	Name fallback brand name: Dorzolamide Hydrochloride generic name: DORZOLAMIDE HYDROCHLORIDE
Dorzolamide Hydrochloride	DORZOLAMIDE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	fb2e0729-b0bc-4c3f-9961-8bb38f84a032	2024-08-27	Warnings, Adverse reactions	Name fallback brand name: Dorzolamide Hydrochloride generic name: DORZOLAMIDE HYDROCHLORIDE
Dorzolamide hydrochloride	DORZOLAMIDE HYDROCHLORIDE	Leading Pharma, LLC	7d4cb6cd-86d0-41d9-baa9-bca0fa7b0694	2024-05-24	Warnings, Adverse reactions	Name fallback brand name: Dorzolamide hydrochloride 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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-5280	DORZOLAMIDE HYDROCHLORIDE	dorzolamide hydrochloride	A-S Medication Solutions	ANDA	Current
50090-5280	DORZOLAMIDE HYDROCHLORIDE	dorzolamide hydrochloride	A-S Medication Solutions	ANDA	Current
61314-019	DORZOLAMIDE HYDROCHLORIDE	dorzolamide hydrochloride	Sandoz Inc	ANDA	Current
61314-019	DORZOLAMIDE HYDROCHLORIDE	dorzolamide hydrochloride	Sandoz Inc	ANDA	Current
61314-019	DORZOLAMIDE HYDROCHLORIDE	dorzolamide hydrochloride	Sandoz Inc	ANDA	Current
61314-019	DORZOLAMIDE HYDROCHLORIDE	dorzolamide hydrochloride	Sandoz Inc	ANDA	Current
61314-019	DORZOLAMIDE HYDROCHLORIDE	dorzolamide hydrochloride	Sandoz Inc	ANDA	Current