Home Applications 040062 Application 040062
Type ANDA
Sponsor MIKART 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 Yes
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 A040062-001 METHAZOLAMIDE METHAZOLAMIDE 25MG TABLET / ORAL AB 1994-01-27 A040062-002 METHAZOLAMIDE METHAZOLAMIDE 50MG TABLET / ORAL AB RS 1994-01-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A040062-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 1994-01-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040062-002 METHAZOLAMIDE 50MG TABLET / ORAL AB RS 1994-01-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040062-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 1994-01-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040062-002 METHAZOLAMIDE 50MG TABLET / ORAL AB RS 1994-01-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040062-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 1994-01-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040062-002 METHAZOLAMIDE 50MG TABLET / ORAL AB RS 1994-01-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040062-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 1994-01-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040062-002 METHAZOLAMIDE 50MG TABLET / ORAL AB RS 1994-01-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040062-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 1994-01-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040062-002 METHAZOLAMIDE 50MG TABLET / ORAL AB RS 1994-01-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040062-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 1994-01-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040062-002 METHAZOLAMIDE 50MG TABLET / ORAL AB RS 1994-01-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040062-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 1994-01-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040062-002 METHAZOLAMIDE 50MG TABLET / ORAL AB RS 1994-01-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040062-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 1994-01-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040062-002 METHAZOLAMIDE 50MG TABLET / ORAL AB RS 1994-01-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040062-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 1994-01-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040062-002 METHAZOLAMIDE 50MG TABLET / ORAL AB RS 1994-01-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040062-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 1994-01-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040062-002 METHAZOLAMIDE 50MG TABLET / ORAL AB RS 1994-01-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040062-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 1994-01-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040062-002 METHAZOLAMIDE 50MG TABLET / ORAL AB RS 1994-01-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040062-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 1994-01-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040062-002 METHAZOLAMIDE 50MG TABLET / ORAL AB RS 1994-01-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040062-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 1994-01-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040062-002 METHAZOLAMIDE 50MG TABLET / ORAL AB RS 1994-01-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040062-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 1994-01-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040062-002 METHAZOLAMIDE 50MG TABLET / ORAL AB RS 1994-01-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040062-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 1994-01-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A040062-002 METHAZOLAMIDE 50MG TABLET / ORAL AB RS 1994-01-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040062-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 1994-01-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040062-002 METHAZOLAMIDE 50MG TABLET / ORAL AB RS 1994-01-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040062-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 1994-01-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A040062-002 METHAZOLAMIDE 50MG TABLET / ORAL AB RS 1994-01-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040062-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 1994-01-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A040062-002 METHAZOLAMIDE 50MG TABLET / ORAL AB RS 1994-01-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040062-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 1994-01-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A040062-002 METHAZOLAMIDE 50MG TABLET / ORAL AB RS 1994-01-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040062-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 1994-01-27 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A040062-002 METHAZOLAMIDE 50MG TABLET / ORAL AB RS 1994-01-27 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
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 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 19 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0574-0790 methazolamide methazolamide Paddock Laboratories, LLC ANDA Current 0574-0790 methazolamide methazolamide Padagis US LLC ANDA Current 0574-0791 methazolamide methazolamide Paddock Laboratories, LLC ANDA Current 0574-0791 methazolamide methazolamide Padagis US LLC ANDA Current 46672-109 Methazolamide methazolamide Mikart, LLC ANDA Current 46672-109 Methazolamide methazolamide Mikart, LLC ANDA Current 46672-109 Methazolamide methazolamide Mikart, LLC ANDA Current 46672-110 Methazolamide methazolamide Mikart, LLC ANDA Current 46672-110 Methazolamide methazolamide Mikart, LLC ANDA Current 46672-110 Methazolamide methazolamide Mikart, LLC ANDA Current 50090-3233 methazolamide methazolamide A-S Medication Solutions ANDA Current 50090-3233 methazolamide methazolamide A-S Medication Solutions ANDA Current 55806-020 methazolamide methazolamide Effcon Laboratories, Inc. ANDA Current 55806-020 methazolamide methazolamide Effcon Laboratories, Inc. ANDA Current 55806-020 methazolamide methazolamide Effcon Laboratories, Inc. ANDA Current 55806-021 methazolamide methazolamide Effcon Laboratories, Inc. ANDA Current 55806-021 methazolamide methazolamide Effcon Laboratories, Inc. ANDA Current 55806-021 methazolamide methazolamide Effcon Laboratories, Inc. ANDA Current 68151-3110 Methazolamide methazolamide Carilion Materials Management ANDA Current