Application 040102

Type: ANDA
Sponsor: INVATECH

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 44.

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
A040102-001	METHAZOLAMIDE	METHAZOLAMIDE	25MG	TABLET / ORAL			1996-08-28
A040102-002	METHAZOLAMIDE	METHAZOLAMIDE	50MG	TABLET / ORAL			1996-08-28

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A040102-001	METHAZOLAMIDE	25MG	TABLET / ORAL	1996-08-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040102-002	METHAZOLAMIDE	50MG	TABLET / ORAL	1996-08-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040102-001	METHAZOLAMIDE	25MG	TABLET / ORAL	1996-08-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040102-002	METHAZOLAMIDE	50MG	TABLET / ORAL	1996-08-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040102-001	METHAZOLAMIDE	25MG	TABLET / ORAL	1996-08-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040102-002	METHAZOLAMIDE	50MG	TABLET / ORAL	1996-08-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040102-001	METHAZOLAMIDE	25MG	TABLET / ORAL	1996-08-28	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040102-002	METHAZOLAMIDE	50MG	TABLET / ORAL	1996-08-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040102-001	METHAZOLAMIDE	25MG	TABLET / ORAL	1996-08-28	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A040102-002	METHAZOLAMIDE	50MG	TABLET / ORAL	1996-08-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040102-001	METHAZOLAMIDE	25MG	TABLET / ORAL	1996-08-28	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A040102-002	METHAZOLAMIDE	50MG	TABLET / ORAL	1996-08-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040102-001	METHAZOLAMIDE	25MG	TABLET / ORAL	1996-08-28	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A040102-002	METHAZOLAMIDE	50MG	TABLET / ORAL	1996-08-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040102-001	METHAZOLAMIDE	25MG	TABLET / ORAL	1996-08-28	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A040102-002	METHAZOLAMIDE	50MG	TABLET / ORAL	1996-08-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040102-001	METHAZOLAMIDE	25MG	TABLET / ORAL	1996-08-28	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A040102-002	METHAZOLAMIDE	50MG	TABLET / ORAL	1996-08-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040102-001	METHAZOLAMIDE	25MG	TABLET / ORAL	1996-08-28	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A040102-002	METHAZOLAMIDE	50MG	TABLET / ORAL	1996-08-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040102-001	METHAZOLAMIDE	25MG	TABLET / ORAL	1996-08-28	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040102-002	METHAZOLAMIDE	50MG	TABLET / ORAL	1996-08-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040102-001	METHAZOLAMIDE	25MG	TABLET / ORAL	1996-08-28	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A040102-002	METHAZOLAMIDE	50MG	TABLET / ORAL	1996-08-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040102-001	METHAZOLAMIDE	25MG	TABLET / ORAL	1996-08-28	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A040102-002	METHAZOLAMIDE	50MG	TABLET / ORAL	1996-08-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040102-001	METHAZOLAMIDE	25MG	TABLET / ORAL	1996-08-28	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040102-002	METHAZOLAMIDE	50MG	TABLET / ORAL	1996-08-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040102-001	METHAZOLAMIDE	25MG	TABLET / ORAL	1996-08-28	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040102-002	METHAZOLAMIDE	50MG	TABLET / ORAL	1996-08-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040102-001	METHAZOLAMIDE	25MG	TABLET / ORAL	1996-08-28	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040102-002	METHAZOLAMIDE	50MG	TABLET / ORAL	1996-08-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040102-001	METHAZOLAMIDE	25MG	TABLET / ORAL	1996-08-28	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040102-002	METHAZOLAMIDE	50MG	TABLET / ORAL	1996-08-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040102-001	METHAZOLAMIDE	25MG	TABLET / ORAL	1996-08-28	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A040102-002	METHAZOLAMIDE	50MG	TABLET / ORAL	1996-08-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040102-001	METHAZOLAMIDE	25MG	TABLET / ORAL	1996-08-28	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A040102-002	METHAZOLAMIDE	50MG	TABLET / ORAL	1996-08-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040102-001	METHAZOLAMIDE	25MG	TABLET / ORAL	1996-08-28	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040102-002	METHAZOLAMIDE	50MG	TABLET / ORAL	1996-08-28	`3a93d1ddd44b…`

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 · 11 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	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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.