Application 040036

Type: ANDA
Sponsor: SANDOZ

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
A040036-001	METHAZOLAMIDE	METHAZOLAMIDE	25MG	TABLET / ORAL	AB		1993-06-30
A040036-002	METHAZOLAMIDE	METHAZOLAMIDE	50MG	TABLET / ORAL	AB		1993-06-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040036-001	AB
A040036-002	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	A040036-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	1993-06-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040036-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	1993-06-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040036-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	1993-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040036-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	1993-06-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040036-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	1993-06-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040036-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	1993-06-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040036-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	1993-06-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040036-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	1993-06-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040036-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	1993-06-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040036-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	1993-06-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040036-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	1993-06-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040036-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	1993-06-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040036-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	1993-06-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040036-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	1993-06-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040036-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	1993-06-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040036-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	1993-06-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040036-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	1993-06-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040036-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	1993-06-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040036-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	1993-06-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040036-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	1993-06-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040036-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	1993-06-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040036-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	1993-06-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040036-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	1993-06-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040036-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	1993-06-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040036-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	1993-06-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040036-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	1993-06-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040036-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	1993-06-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040036-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	1993-06-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040036-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	1993-06-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040036-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	1993-06-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040036-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	1993-06-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040036-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	1993-06-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040036-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	1993-06-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040036-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	1993-06-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040036-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	1993-06-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040036-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	1993-06-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040036-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	1993-06-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040036-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	1993-06-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040036-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	1993-06-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040036-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	1993-06-30	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A040036-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040036-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040036-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040036-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040036-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040036-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040036-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040036-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040036-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040036-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040036-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040036-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040036-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040036-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040036-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040036-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040036-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040036-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040036-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040036-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040036-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040036-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040036-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040036-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040036-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040036-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040036-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040036-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040036-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040036-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040036-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040036-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040036-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040036-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040036-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040036-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040036-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040036-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040036-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040036-002	AB	1	`bb7c543d1eb4…`

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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methazolamide	METHAZOLAMIDE	Bryant Ranch Prepack	ff710572-ed62-490a-95f1-2b2c2eed08ee	2026-03-27	Warnings, Adverse reactions	Name fallback brand name: Methazolamide generic name: METHAZOLAMIDE
Methazolamide	METHAZOLAMIDE	Bryant Ranch Prepack	1698aa2d-a962-4bcc-8646-4fff532b645b	2026-03-27	Warnings, Adverse reactions	Name fallback brand name: Methazolamide generic name: METHAZOLAMIDE
Methazolamide	METHAZOLAMIDE	Bryant Ranch Prepack	504b695a-ac9e-4c71-8755-d31f1958a71c	2026-03-25	Warnings, Adverse reactions	Name fallback brand name: Methazolamide generic name: METHAZOLAMIDE
Methazolamide	METHAZOLAMIDE	Bryant Ranch Prepack	369e89a4-9898-4a9f-a316-17d0fce8a08b	2026-03-25	Warnings, Adverse reactions	Name fallback brand name: Methazolamide generic name: METHAZOLAMIDE
Methazolamide	METHAZOLAMIDE	Ajanta Pharma USA Inc.	879a3c78-24dd-41f9-8fce-5f3166b0e2f4	2026-02-10	Warnings, Adverse reactions	Name fallback brand name: Methazolamide generic name: METHAZOLAMIDE
Methazolamide	METHAZOLAMIDE	Golden State Medical Supply, Inc.	723f830c-a534-55d1-e053-2a91aa0a403c	2025-12-11	Warnings, Adverse reactions	Name fallback brand name: Methazolamide generic name: METHAZOLAMIDE
Methazolamide	METHAZOLAMIDE	ANI Pharmaceuticals, Inc.	c26c8834-961e-4c9c-9ad4-5db2d9419938	2025-11-26	Warnings, Adverse reactions	Name fallback brand name: Methazolamide generic name: METHAZOLAMIDE
Methazolamide	METHAZOLAMIDE	Bausch & Lomb Incorporated	0c0ba5c7-c53e-4e29-a7ff-48fddc5a9258	2025-10-23	Warnings, Adverse reactions	Name fallback brand name: Methazolamide generic name: METHAZOLAMIDE
Methazolamide	METHAZOLAMIDE	Precision Dose, Inc.	1e0e81c7-a328-4034-a6b3-4c83e9ac3a3e	2023-12-04	Warnings, Adverse reactions	Name fallback brand name: Methazolamide generic name: METHAZOLAMIDE
Methazolamide	METHAZOLAMIDE	NorthStar Rx LLC	042586b3-4d49-c5ae-e063-6394a90aaa7c	2023-08-30	Warnings, Adverse reactions	Name fallback brand name: Methazolamide generic name: METHAZOLAMIDE
methazolamide	METHAZOLAMIDE	Padagis US LLC	5e0795e1-d5c5-4b04-9bce-077bb8028023	2023-05-01	Warnings, Adverse reactions	Name fallback brand name: methazolamide generic name: METHAZOLAMIDE
METHAZOLAMIDE	METHAZOLAMIDE	Micro Labs Limited	91a493f5-f8c3-4b64-a15e-b550d8631668	2020-02-17	Warnings, Adverse reactions	Name fallback brand name: METHAZOLAMIDE generic name: METHAZOLAMIDE

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
0781-1071	Methazolamide	Methazolamide	Sandoz Inc	ANDA	Current
0781-1071	Methazolamide	Methazolamide	Sandoz Inc	ANDA	Current
0781-1072	Methazolamide	Methazolamide	Sandoz Inc	ANDA	Current
0781-1072	Methazolamide	Methazolamide	Sandoz Inc	ANDA	Current