Application 215101

Type: ANDA
Sponsor: RUBICON

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 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
A215101-001	ACETAZOLAMIDE	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB		2021-08-19
A215101-002	ACETAZOLAMIDE	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB		2021-08-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215101-001	AB
A215101-002	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 2 · 66 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
2026-02-19 14:30 UTC	2026-02	A215101-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2021-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215101-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2021-08-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215101-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2021-08-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215101-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2021-08-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215101-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2021-08-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215101-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2021-08-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215101-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2021-08-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215101-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2021-08-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215101-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2021-08-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215101-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2021-08-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215101-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2021-08-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215101-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2021-08-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215101-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2021-08-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215101-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2021-08-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215101-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2021-08-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215101-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2021-08-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215101-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2021-08-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215101-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2021-08-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215101-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2021-08-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215101-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2021-08-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215101-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2021-08-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215101-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2021-08-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215101-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2021-08-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215101-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2021-08-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215101-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2021-08-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215101-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2021-08-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215101-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2021-08-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215101-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2021-08-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215101-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2021-08-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215101-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2021-08-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215101-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2021-08-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A215101-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2021-08-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215101-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2021-08-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A215101-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2021-08-19	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215101-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2021-08-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A215101-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2021-08-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A215101-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2021-08-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A215101-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2021-08-19	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215101-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2021-08-19	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215101-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2021-08-19	`6a51e52b5d6a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 66 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	A215101-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215101-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215101-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215101-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215101-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215101-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215101-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215101-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215101-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215101-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215101-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215101-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215101-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215101-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215101-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215101-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215101-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215101-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215101-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215101-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215101-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215101-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215101-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215101-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215101-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215101-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215101-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215101-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215101-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215101-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215101-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A215101-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215101-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A215101-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215101-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A215101-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A215101-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A215101-002	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215101-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215101-002	AB	1	`6a51e52b5d6a…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acetazolamide	ACETAZOLAMIDE	Bryant Ranch Prepack	71f1fbbb-428e-4bf7-bc20-2946c1079bd3	2026-05-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215101 application number: ANDA215101
Acetazolamide	ACETAZOLAMIDE	Advagen Pharma Ltd	c24d31f0-a556-4e53-97a9-4e05e28ca40f	2025-11-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215101 application number: ANDA215101 ndc (product): 72888-047 ndc (product): 72888-048
Acetazolamide	ACETAZOLAMIDE	NuCare Pharmaceuticals,Inc.	0b76c194-b244-e9ac-e063-6394a90a373e	2025-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215101 application number: ANDA215101

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
72888-047	Acetazolamide	Acetazolamide	Advagen Pharma Ltd	ANDA	Current
72888-048	Acetazolamide	Acetazolamide	Advagen Pharma Ltd	ANDA	Current