Application 207438

Type: ANDA
Sponsor: MICRO LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METHAZOLAMIDE	METHAZOLAMIDE	TABLET;ORAL	25MG	No	No
002	METHAZOLAMIDE	METHAZOLAMIDE	TABLET;ORAL	50MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A207438-001	METHAZOLAMIDE	METHAZOLAMIDE	25MG	TABLET / ORAL	AB		2018-10-05
A207438-002	METHAZOLAMIDE	METHAZOLAMIDE	50MG	TABLET / ORAL	AB		2018-10-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207438-001	AB
A207438-002	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 · 84 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
2026-08-18 06:07:40	2026-07	A207438-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	2018-10-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207438-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	2018-10-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207438-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	2018-10-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207438-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	2018-10-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207438-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	2018-10-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207438-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	2018-10-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207438-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	2018-10-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207438-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	2018-10-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207438-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	2018-10-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207438-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	2018-10-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207438-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	2018-10-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207438-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	2018-10-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207438-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	2018-10-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207438-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	2018-10-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207438-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	2018-10-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207438-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	2018-10-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207438-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	2018-10-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207438-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	2018-10-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207438-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	2018-10-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207438-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	2018-10-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207438-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	2018-10-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207438-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	2018-10-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207438-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	2018-10-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207438-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	2018-10-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207438-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	2018-10-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207438-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	2018-10-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207438-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	2018-10-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207438-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	2018-10-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207438-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	2018-10-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207438-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	2018-10-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207438-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	2018-10-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207438-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	2018-10-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207438-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	2018-10-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207438-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	2018-10-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207438-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	2018-10-05	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207438-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	2018-10-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207438-001	METHAZOLAMIDE	25MG	TABLET / ORAL		2018-10-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207438-002	METHAZOLAMIDE	50MG	TABLET / ORAL		2018-10-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207438-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	2018-10-05	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207438-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	2018-10-05	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A207438-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207438-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207438-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207438-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207438-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207438-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207438-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207438-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207438-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207438-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207438-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207438-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207438-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207438-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207438-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207438-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207438-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207438-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207438-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207438-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207438-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207438-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207438-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207438-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207438-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207438-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207438-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207438-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207438-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207438-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207438-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207438-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207438-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207438-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207438-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207438-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A207438-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207438-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207438-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207438-002	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methazolamide	METHAZOLAMIDE	Bausch & Lomb Incorporated	0c0ba5c7-c53e-4e29-a7ff-48fddc5a9258	2025-10-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207438 application number: ANDA207438 ndc (product): 24208-023 ndc (product): 24208-022
METHAZOLAMIDE	METHAZOLAMIDE	Micro Labs Limited	91a493f5-f8c3-4b64-a15e-b550d8631668	2020-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207438 application number: ANDA207438 ndc (product): 42571-240 ndc (product): 42571-239

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
24208-022	Methazolamide	methazolamide	Bausch & Lomb Incorporated	ANDA	Current
24208-023	Methazolamide	methazolamide	Bausch & Lomb Incorporated	ANDA	Current
42571-239	METHAZOLAMIDE	Methazolamide	Micro Labs Limited	ANDA	Current
42571-239	METHAZOLAMIDE	Methazolamide	Micro Labs Limited	ANDA	Current
42571-239	METHAZOLAMIDE	Methazolamide	Micro Labs Limited	ANDA	Current
42571-239	METHAZOLAMIDE	Methazolamide	Micro Labs Limited	ANDA	Current
42571-240	METHAZOLAMIDE	Methazolamide	Micro Labs Limited	ANDA	Current
42571-240	METHAZOLAMIDE	Methazolamide	Micro Labs Limited	ANDA	Current
42571-240	METHAZOLAMIDE	Methazolamide	Micro Labs Limited	ANDA	Current
42571-240	METHAZOLAMIDE	Methazolamide	Micro Labs Limited	ANDA	Current
68682-022	Methazolamide	methazolamide	Oceanside Pharmaceuticals	ANDA	Current
68682-023	Methazolamide	methazolamide	Oceanside Pharmaceuticals	ANDA	Current