Application 089753

Type: ANDA
Sponsor: SUN PHARM INDUSTRIES

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ACETAZOLAMIDE	ACETAZOLAMIDE	TABLET;ORAL	250MG	No	No
002	ACETAZOLAMIDE	ACETAZOLAMIDE	TABLET;ORAL	125MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A089753-001	ACETAZOLAMIDE	ACETAZOLAMIDE	250MG	TABLET / ORAL			1988-06-22
A089753-002	ACETAZOLAMIDE	ACETAZOLAMIDE	125MG	TABLET / ORAL			1988-06-22

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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A089753-001	ACETAZOLAMIDE	250MG	TABLET / ORAL	1988-06-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A089753-002	ACETAZOLAMIDE	125MG	TABLET / ORAL	1988-06-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A089753-001	ACETAZOLAMIDE	250MG	TABLET / ORAL	1988-06-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A089753-002	ACETAZOLAMIDE	125MG	TABLET / ORAL	1988-06-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A089753-001	ACETAZOLAMIDE	250MG	TABLET / ORAL	1988-06-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089753-002	ACETAZOLAMIDE	125MG	TABLET / ORAL	1988-06-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089753-001	ACETAZOLAMIDE	250MG	TABLET / ORAL	1988-06-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089753-002	ACETAZOLAMIDE	125MG	TABLET / ORAL	1988-06-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089753-001	ACETAZOLAMIDE	250MG	TABLET / ORAL	1988-06-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089753-002	ACETAZOLAMIDE	125MG	TABLET / ORAL	1988-06-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089753-001	ACETAZOLAMIDE	250MG	TABLET / ORAL	1988-06-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089753-002	ACETAZOLAMIDE	125MG	TABLET / ORAL	1988-06-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089753-001	ACETAZOLAMIDE	250MG	TABLET / ORAL	1988-06-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089753-002	ACETAZOLAMIDE	125MG	TABLET / ORAL	1988-06-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089753-001	ACETAZOLAMIDE	250MG	TABLET / ORAL	1988-06-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089753-002	ACETAZOLAMIDE	125MG	TABLET / ORAL	1988-06-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089753-001	ACETAZOLAMIDE	250MG	TABLET / ORAL	1988-06-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089753-002	ACETAZOLAMIDE	125MG	TABLET / ORAL	1988-06-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089753-001	ACETAZOLAMIDE	250MG	TABLET / ORAL	1988-06-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089753-002	ACETAZOLAMIDE	125MG	TABLET / ORAL	1988-06-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089753-001	ACETAZOLAMIDE	250MG	TABLET / ORAL	1988-06-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089753-002	ACETAZOLAMIDE	125MG	TABLET / ORAL	1988-06-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089753-001	ACETAZOLAMIDE	250MG	TABLET / ORAL	1988-06-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A089753-002	ACETAZOLAMIDE	125MG	TABLET / ORAL	1988-06-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089753-001	ACETAZOLAMIDE	250MG	TABLET / ORAL	1988-06-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089753-002	ACETAZOLAMIDE	125MG	TABLET / ORAL	1988-06-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089753-001	ACETAZOLAMIDE	250MG	TABLET / ORAL	1988-06-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089753-002	ACETAZOLAMIDE	125MG	TABLET / ORAL	1988-06-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089753-001	ACETAZOLAMIDE	250MG	TABLET / ORAL	1988-06-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089753-002	ACETAZOLAMIDE	125MG	TABLET / ORAL	1988-06-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089753-001	ACETAZOLAMIDE	250MG	TABLET / ORAL	1988-06-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A089753-002	ACETAZOLAMIDE	125MG	TABLET / ORAL	1988-06-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089753-001	ACETAZOLAMIDE	250MG	TABLET / ORAL	1988-06-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089753-002	ACETAZOLAMIDE	125MG	TABLET / ORAL	1988-06-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089753-001	ACETAZOLAMIDE	250MG	TABLET / ORAL	1988-06-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A089753-002	ACETAZOLAMIDE	125MG	TABLET / ORAL	1988-06-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089753-001	ACETAZOLAMIDE	250MG	TABLET / ORAL	1988-06-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A089753-002	ACETAZOLAMIDE	125MG	TABLET / ORAL	1988-06-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089753-001	ACETAZOLAMIDE	250MG	TABLET / ORAL	1988-06-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A089753-002	ACETAZOLAMIDE	125MG	TABLET / ORAL	1988-06-22	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-09-15 20:21 UTC	2019-09	A089753-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089753-002	AB	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 2 of 3 · 53 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acetazolamide	ACETAZOLAMIDE SODIUM	Sagent Pharmaceuticals	58093032-8480-4d0f-82be-92e643bdbea4	2026-01-09	Warnings, Adverse reactions	Name fallback brand name: Acetazolamide
Acetazolamide	ACETAZOLAMIDE	AvPAK	a9dca448-5511-413e-e053-2a95a90a8c66	2026-01-08	Warnings, Adverse reactions	Name fallback brand name: Acetazolamide generic name: ACETAZOLAMIDE
Acetazolamide	ACETAZOLAMIDE	PD-Rx Pharmaceuticals, Inc.	c525ef20-ec9a-4ffd-b5ea-e53c186fe716	2026-01-05	Warnings, Adverse reactions	Name fallback brand name: Acetazolamide generic name: ACETAZOLAMIDE
acetazolamide	ACETAZOLAMIDE	Northwind Health Company, LLC	f8232eaf-e108-aa00-e053-6394a90aede4	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: acetazolamide generic name: ACETAZOLAMIDE
acetazolamide	ACETAZOLAMIDE	Accord Healthcare Inc.	9a368b35-cd51-47ad-83cc-ccc56c4585e8	2025-12-15	Warnings, Adverse reactions	Name fallback brand name: acetazolamide generic name: ACETAZOLAMIDE
Acetazolamide	ACETAZOLAMIDE	Aarkish Pharmaceuticals NJ Inc.	ddfd44dc-3136-4dda-8ed0-eb2991c2a0b6	2025-12-08	Warnings, Adverse reactions	Name fallback brand name: Acetazolamide generic name: ACETAZOLAMIDE
Acetazolamide	ACETAZOLAMIDE	Eywa Pharma Inc	c19166fa-2cef-4c96-a956-ea540a8ba9c3	2025-12-05	Warnings, Adverse reactions	Name fallback brand name: Acetazolamide generic name: ACETAZOLAMIDE
Acetazolamide	ACETAZOLAMIDE	Ingenus Pharmaceuticals, LLC	a1f6ed35-9188-4115-8a3c-1ac91c07bf7d	2025-12-05	Warnings, Adverse reactions	Name fallback brand name: Acetazolamide generic name: ACETAZOLAMIDE
Acetazolamide	ACETAZOLAMIDE	Ajanta Pharma USA Inc.	240ab24b-3124-4805-80c2-36dd1945e3b3	2025-12-02	Warnings, Adverse reactions	Name fallback brand name: Acetazolamide generic name: ACETAZOLAMIDE
Acetazolamide	ACETAZOLAMIDE	Advagen Pharma Ltd	c24d31f0-a556-4e53-97a9-4e05e28ca40f	2025-11-12	Warnings, Adverse reactions	Name fallback brand name: Acetazolamide generic name: ACETAZOLAMIDE
ACETAZOLAMIDE	ACETAZOLAMIDE	Aurobindo Pharma Limited	513da48f-8f12-4696-b862-e8d882bf8611	2025-11-03	Warnings, Adverse reactions	Name fallback brand name: ACETAZOLAMIDE generic name: ACETAZOLAMIDE
AcetaZOLAMIDE	ACETAZOLAMIDE	Hikma Pharmaceuticals USA Inc.	5502e5ba-9b5e-460a-855f-60534b625461	2025-11-03	Warnings, Adverse reactions	Name fallback brand name: AcetaZOLAMIDE generic name: ACETAZOLAMIDE
acetaZOLAMIDE	ACETAZOLAMIDE	Viona Pharmaceuticals Inc	5473c171-dc2d-4a82-bbf1-0f5fad10f673	2025-11-03	Warnings, Adverse reactions	Name fallback brand name: acetaZOLAMIDE generic name: ACETAZOLAMIDE
acetaZOLAMIDE	ACETAZOLAMIDE	Zydus Lifesciences Limited	df84fea3-8947-403f-b470-1eeb6c4c293d	2025-10-31	Warnings, Adverse reactions	Name fallback brand name: acetaZOLAMIDE generic name: ACETAZOLAMIDE
Acetazolamide	ACETAZOLAMIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	60f656ff-97b1-4a89-99af-8100483c2bac	2025-06-25	Warnings, Adverse reactions	Name fallback brand name: Acetazolamide generic name: ACETAZOLAMIDE
Acetazolamide	ACETAZOLAMIDE	Gland Pharma Limited	2b9fb0dd-e42e-4f9b-bf24-98b268d877e5	2025-06-18	Warnings, Adverse reactions	Name fallback brand name: Acetazolamide generic name: ACETAZOLAMIDE
Acetazolamide	ACETAZOLAMIDE	XGen Pharmaceuticals DJB, Inc.	a9199d3c-ce52-4db5-aa36-408f4e15e344	2025-06-02	Warnings, Adverse reactions	Name fallback brand name: Acetazolamide generic name: ACETAZOLAMIDE
acetazolamide	ACETAZOLAMIDE	American Health Packaging	4e8797d9-2e78-49e0-af25-ac5d1f792499	2025-05-30	Warnings, Adverse reactions	Name fallback brand name: acetazolamide generic name: ACETAZOLAMIDE
Acetazolamide	ACETAZOLAMIDE SODIUM	Mylan Institutional LLC	521838b0-a10d-495f-a014-f9ff25a6b6f3	2025-02-17	Warnings, Adverse reactions	Name fallback brand name: Acetazolamide
AcetaZOLAMIDE	ACETAZOLAMIDE	Hikma Pharmaceuticals USA Inc.	85975cf0-1286-4af9-ac7f-94bb2483bf09	2025-02-04	Warnings, Adverse reactions	Name fallback brand name: AcetaZOLAMIDE generic name: ACETAZOLAMIDE

Reported adverse events (FAERS/openFDA)#

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