Application 207503

Type: ANDA
Sponsor: BRECKENRIDGE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ACETAZOLAMIDE	ACETAZOLAMIDE	TABLET;ORAL	125MG	No	No
002	ACETAZOLAMIDE	ACETAZOLAMIDE	TABLET;ORAL	250MG	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
A207503-001	ACETAZOLAMIDE	ACETAZOLAMIDE	125MG	TABLET / ORAL			2020-04-30
A207503-002	ACETAZOLAMIDE	ACETAZOLAMIDE	250MG	TABLET / ORAL			2020-04-30

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 · 78 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
2026-09-14 22:38:34	2026-08	A207503-001	ACETAZOLAMIDE	125MG	TABLET / ORAL		2020-04-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207503-002	ACETAZOLAMIDE	250MG	TABLET / ORAL		2020-04-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207503-001	ACETAZOLAMIDE	125MG	TABLET / ORAL		2020-04-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207503-002	ACETAZOLAMIDE	250MG	TABLET / ORAL		2020-04-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207503-001	ACETAZOLAMIDE	125MG	TABLET / ORAL		2020-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207503-002	ACETAZOLAMIDE	250MG	TABLET / ORAL		2020-04-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207503-001	ACETAZOLAMIDE	125MG	TABLET / ORAL		2020-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207503-002	ACETAZOLAMIDE	250MG	TABLET / ORAL		2020-04-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207503-001	ACETAZOLAMIDE	125MG	TABLET / ORAL		2020-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207503-002	ACETAZOLAMIDE	250MG	TABLET / ORAL		2020-04-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207503-001	ACETAZOLAMIDE	125MG	TABLET / ORAL		2020-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207503-002	ACETAZOLAMIDE	250MG	TABLET / ORAL		2020-04-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207503-001	ACETAZOLAMIDE	125MG	TABLET / ORAL		2020-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207503-002	ACETAZOLAMIDE	250MG	TABLET / ORAL		2020-04-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207503-001	ACETAZOLAMIDE	125MG	TABLET / ORAL		2020-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207503-002	ACETAZOLAMIDE	250MG	TABLET / ORAL		2020-04-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207503-001	ACETAZOLAMIDE	125MG	TABLET / ORAL		2020-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207503-002	ACETAZOLAMIDE	250MG	TABLET / ORAL		2020-04-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207503-001	ACETAZOLAMIDE	125MG	TABLET / ORAL		2020-04-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207503-002	ACETAZOLAMIDE	250MG	TABLET / ORAL		2020-04-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207503-001	ACETAZOLAMIDE	125MG	TABLET / ORAL		2020-04-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207503-002	ACETAZOLAMIDE	250MG	TABLET / ORAL		2020-04-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207503-001	ACETAZOLAMIDE	125MG	TABLET / ORAL		2020-04-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207503-002	ACETAZOLAMIDE	250MG	TABLET / ORAL		2020-04-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207503-001	ACETAZOLAMIDE	125MG	TABLET / ORAL		2020-04-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207503-002	ACETAZOLAMIDE	250MG	TABLET / ORAL		2020-04-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207503-001	ACETAZOLAMIDE	125MG	TABLET / ORAL		2020-04-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207503-002	ACETAZOLAMIDE	250MG	TABLET / ORAL		2020-04-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207503-001	ACETAZOLAMIDE	125MG	TABLET / ORAL		2020-04-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207503-002	ACETAZOLAMIDE	250MG	TABLET / ORAL		2020-04-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207503-001	ACETAZOLAMIDE	125MG	TABLET / ORAL		2020-04-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207503-002	ACETAZOLAMIDE	250MG	TABLET / ORAL		2020-04-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207503-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2020-04-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207503-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2020-04-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207503-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2020-04-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207503-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2020-04-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207503-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2020-04-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207503-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2020-04-30	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A207503-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2020-04-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207503-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2020-04-30	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207503-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207503-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207503-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207503-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207503-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207503-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A207503-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207503-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207503-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207503-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207503-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207503-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207503-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A207503-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207503-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A207503-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207503-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A207503-002	AB	1	`c0c555d07b60…`
2023-01-26 05:58 UTC	2023-01	A207503-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A207503-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207503-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207503-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207503-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A207503-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207503-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A207503-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207503-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207503-002	AB	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 3 of 3 · 53 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acetazolamide	ACETAZOLAMIDE	NuCare Pharmaceuticals,Inc.	0b76c194-b244-e9ac-e063-6394a90a373e	2025-02-03	Warnings, Adverse reactions	Name fallback brand name: Acetazolamide generic name: ACETAZOLAMIDE
Acetazolamide	ACETAZOLAMIDE	NuCare Pharmaceuticlas, Inc.	278878bc-da9c-09d4-e063-6394a90abaf7	2024-11-22	Warnings, Adverse reactions	Name fallback brand name: Acetazolamide generic name: ACETAZOLAMIDE
Acetazolamide	ACETAZOLAMIDE	Bryant Ranch Prepack	923031ec-8142-4570-b3a6-210441d97105	2024-10-29	Warnings, Adverse reactions	Name fallback brand name: Acetazolamide generic name: ACETAZOLAMIDE
Acetazolamide	ACETAZOLAMIDE	Chartwell RX, LLC	e8e48a25-5f6c-4b5a-a5f2-ee87aabea33b	2024-10-10	Warnings, Adverse reactions	Name fallback brand name: Acetazolamide generic name: ACETAZOLAMIDE
Acetazolamide	ACETAZOLAMIDE	Chartwell RX, LLC	f75bbf55-98ac-4f91-b6fd-17b5ac860e55	2024-10-10	Warnings, Adverse reactions	Name fallback brand name: Acetazolamide generic name: ACETAZOLAMIDE
acetazolamide	ACETAZOLAMIDE	Zydus Pharmaceuticals (USA) Inc.	bf514e99-4958-44a0-a87a-02a950f87e60	2024-10-08	Warnings, Adverse reactions	Name fallback brand name: acetazolamide generic name: ACETAZOLAMIDE
acetazolamide	ACETAZOLAMIDE	Zydus Lifesciences Limited	2c1d9078-c15f-4dce-bc26-edfa5400fa9b	2024-10-08	Warnings, Adverse reactions	Name fallback brand name: acetazolamide generic name: ACETAZOLAMIDE
Acetazolamide	ACETAZOLAMIDE	Alembic Pharmaceuticals Inc.	43231abb-2a5d-44ab-b3e6-7564a1131ac5	2024-09-30	Warnings, Adverse reactions	Name fallback brand name: Acetazolamide generic name: ACETAZOLAMIDE
acetaZOLAMIDE	ACETAZOLAMIDE	NuCare Pharmaceuticals,Inc.	1b2c973f-82ef-a4f3-e063-6394a90aaae0	2024-08-09	Warnings, Adverse reactions	Name fallback brand name: acetaZOLAMIDE generic name: ACETAZOLAMIDE
acetaZOLAMIDE	ACETAZOLAMIDE	Zydus Pharmaceuticals (USA) Inc.	85e4d8f6-1e82-4068-a768-752287d4ccf2	2024-03-26	Warnings, Adverse reactions	Name fallback brand name: acetaZOLAMIDE generic name: ACETAZOLAMIDE
ACETAZOLAMIDE	ACETAZOLAMIDE	TRUPHARMA, LLC	4fcd428a-7bf3-4e75-a834-1bdf1078107f	2022-06-13	Warnings, Adverse reactions	Name fallback brand name: ACETAZOLAMIDE generic name: ACETAZOLAMIDE
Acetazolamide	ACETAZOLAMIDE	Proficient Rx LP	3cdde6aa-c89d-4ea4-aade-6c8b5c3ffdcc	2019-10-01	Warnings, Adverse reactions	Name fallback brand name: Acetazolamide generic name: ACETAZOLAMIDE
Acetazolamide	ACETAZOLAMIDE	Alembic Pharmaceuticals Limited	d9c1cc75-4e3d-4eaf-87c5-d5942a843818	2019-02-20	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.

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
51991-884	AcetaZOLAMIDE	Acetazolamide	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-884	AcetaZOLAMIDE	Acetazolamide	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-885	AcetaZOLAMIDE	Acetazolamide	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-885	AcetaZOLAMIDE	Acetazolamide	Breckenridge Pharmaceutical, Inc.	ANDA	Current