Application 040195

Type: ANDA
Sponsor: TARO

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	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A040195-001	ACETAZOLAMIDE	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB		1997-05-28
A040195-002	ACETAZOLAMIDE	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	RS	1997-05-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A040195-001	AB
A040195-002	AB

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 · 82 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
2026-02-19 14:30 UTC	2026-02	A040195-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB		1997-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040195-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	RS	1997-05-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040195-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB		1997-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040195-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	RS	1997-05-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040195-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB		1997-05-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040195-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	RS	1997-05-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040195-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB		1997-05-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040195-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	RS	1997-05-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040195-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB		1997-05-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040195-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	RS	1997-05-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040195-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB		1997-05-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040195-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	RS	1997-05-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040195-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB		1997-05-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040195-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	RS	1997-05-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040195-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB		1997-05-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040195-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	RS	1997-05-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040195-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB		1997-05-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040195-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	RS	1997-05-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040195-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB		1997-05-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040195-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	RS	1997-05-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040195-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB		1997-05-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040195-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	RS	1997-05-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040195-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB		1997-05-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040195-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	RS	1997-05-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040195-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB		1997-05-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040195-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	RS	1997-05-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040195-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB		1997-05-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040195-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	RS	1997-05-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040195-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB		1997-05-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040195-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	RS	1997-05-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040195-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB		1997-05-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040195-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	RS	1997-05-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040195-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB		1997-05-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040195-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	RS	1997-05-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040195-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB		1997-05-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040195-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	RS	1997-05-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040195-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB		1997-05-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040195-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	RS	1997-05-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040195-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB		1997-05-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040195-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	RS	1997-05-28	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040195-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040195-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040195-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040195-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040195-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040195-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040195-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040195-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040195-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040195-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040195-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040195-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040195-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040195-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040195-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040195-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040195-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040195-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040195-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040195-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040195-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040195-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040195-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040195-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040195-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040195-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040195-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040195-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040195-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040195-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040195-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040195-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040195-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040195-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040195-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040195-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040195-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040195-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040195-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040195-002	AB	1	`782e0a99824c…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acetazolamide	ACETAZOLAMIDE	PD-Rx Pharmaceuticals, Inc.	bd911de5-ea56-41ba-a328-20c8bfe7fe3b	2025-05-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040195 application number: ANDA040195 ndc (product): 55289-720

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-1511	AcetaZOLAMIDE	AcetaZOLAMIDE	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
50090-0279	Acetazolamide	Acetazolamide	A-S Medication Solutions	ANDA	Current
50090-0577	Acetazolamide	Acetazolamide	A-S Medication Solutions	ANDA	Current
50090-0577	Acetazolamide	Acetazolamide	A-S Medication Solutions	ANDA	Current
51672-4022	Acetazolamide	Acetazolamide	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4023	Acetazolamide	Acetazolamide	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
55289-221	Acetazolamide	Acetazolamide	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-720	Acetazolamide	Acetazolamide	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-720	Acetazolamide	Acetazolamide	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-720	Acetazolamide	Acetazolamide	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-720	Acetazolamide	Acetazolamide	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-720	Acetazolamide	Acetazolamide	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-720	Acetazolamide	Acetazolamide	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
60429-033	Acetazolamide	Acetazolamide	Golden State Medical Supply, Inc.	ANDA	Current
60429-034	Acetazolamide	Acetazolamide	Golden State Medical Supply, Inc.	ANDA	Current