Application 214282

Type: ANDA
Sponsor: MANKIND PHARMA

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
A214282-001	ACETAZOLAMIDE	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB		2020-10-07
A214282-002	ACETAZOLAMIDE	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB		2020-10-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214282-001	AB
A214282-002	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 · 74 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	A214282-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2020-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214282-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2020-10-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214282-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2020-10-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214282-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2020-10-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214282-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2020-10-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214282-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2020-10-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214282-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2020-10-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214282-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2020-10-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214282-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2020-10-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214282-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2020-10-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214282-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2020-10-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214282-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2020-10-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214282-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2020-10-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214282-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2020-10-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214282-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2020-10-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214282-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2020-10-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214282-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2020-10-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214282-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2020-10-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214282-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2020-10-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214282-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2020-10-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214282-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2020-10-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214282-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2020-10-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214282-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2020-10-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214282-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2020-10-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214282-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2020-10-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214282-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2020-10-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214282-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2020-10-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214282-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2020-10-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214282-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2020-10-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214282-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2020-10-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214282-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2020-10-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A214282-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2020-10-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214282-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2020-10-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A214282-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2020-10-07	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214282-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2020-10-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A214282-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2020-10-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214282-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2020-10-07	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A214282-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2020-10-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A214282-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2020-10-07	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A214282-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2020-10-07	`87673890dc5c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 72 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	A214282-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214282-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214282-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214282-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214282-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214282-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214282-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214282-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214282-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214282-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214282-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214282-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214282-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214282-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214282-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214282-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214282-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214282-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214282-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214282-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214282-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214282-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214282-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214282-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214282-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214282-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214282-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214282-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214282-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214282-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214282-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A214282-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214282-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A214282-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214282-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A214282-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214282-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A214282-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A214282-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A214282-002	AB	1	`87673890dc5c…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acetazolamide	ACETAZOLAMIDE	Bryant Ranch Prepack	9af15152-d46f-4bc3-a16e-b70a472bc52a	2026-03-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214282 application number: ANDA214282
Acetazolamide	ACETAZOLAMIDE	Bryant Ranch Prepack	84a582a9-c7e5-4159-a5eb-a47a96b4afc0	2026-03-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214282 application number: ANDA214282
Acetazolamide	ACETAZOLAMIDE	Bryant Ranch Prepack	f7227cc5-0a80-47df-baf8-09f1b22b187e	2026-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214282 application number: ANDA214282 ndc (product): 63629-1194
Acetazolamide	ACETAZOLAMIDE	Lifestar Pharma LLC	0913db35-3f08-4d82-8394-486bd9a487c4	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214282 application number: ANDA214282 ndc (product): 70756-720 ndc (product): 70756-721
Acetazolamide	ACETAZOLAMIDE	Bryant Ranch Prepack	923031ec-8142-4570-b3a6-210441d97105	2024-10-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214282 application number: ANDA214282 ndc (product): 63629-1195

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63629-1194	Acetazolamide	Acetazolamide	Bryant Ranch Prepack	ANDA	Current
63629-1194	Acetazolamide	Acetazolamide	Bryant Ranch Prepack	ANDA	Current
63629-1194	Acetazolamide	Acetazolamide	Bryant Ranch Prepack	ANDA	Current
63629-1194	Acetazolamide	Acetazolamide	Bryant Ranch Prepack	ANDA	Current
63629-1195	Acetazolamide	Acetazolamide	Bryant Ranch Prepack	ANDA	Current
63629-1195	Acetazolamide	Acetazolamide	Bryant Ranch Prepack	ANDA	Current
63629-1195	Acetazolamide	Acetazolamide	Bryant Ranch Prepack	ANDA	Current
63629-1195	Acetazolamide	Acetazolamide	Bryant Ranch Prepack	ANDA	Current
70756-720	Acetazolamide	Acetazolamide	Lifestar Pharma LLC	ANDA	Current
70756-720	Acetazolamide	Acetazolamide	Lifestar Pharma LLC	ANDA	Current
70756-720	Acetazolamide	Acetazolamide	Lifestar Pharma LLC	ANDA	Current
70756-720	Acetazolamide	Acetazolamide	Lifestar Pharma LLC	ANDA	Current
70756-721	Acetazolamide	Acetazolamide	Lifestar Pharma LLC	ANDA	Current
70756-721	Acetazolamide	Acetazolamide	Lifestar Pharma LLC	ANDA	Current
70756-721	Acetazolamide	Acetazolamide	Lifestar Pharma LLC	ANDA	Current
70756-721	Acetazolamide	Acetazolamide	Lifestar Pharma LLC	ANDA	Current