Application 040102
- Type
- ANDA
- Sponsor
- INVATECH
Application Products#
| 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 |
Orange Book products#
| 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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A040102-001 | METHAZOLAMIDE | 25MG | TABLET / ORAL | 1996-08-28 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A040102-002 | METHAZOLAMIDE | 50MG | TABLET / ORAL | 1996-08-28 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040102-001 | METHAZOLAMIDE | 25MG | TABLET / ORAL | 1996-08-28 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040102-002 | METHAZOLAMIDE | 50MG | TABLET / ORAL | 1996-08-28 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A040102-001 | METHAZOLAMIDE | 25MG | TABLET / ORAL | 1996-08-28 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A040102-002 | METHAZOLAMIDE | 50MG | TABLET / ORAL | 1996-08-28 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040102-001 | METHAZOLAMIDE | 25MG | TABLET / ORAL | 1996-08-28 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040102-002 | METHAZOLAMIDE | 50MG | TABLET / ORAL | 1996-08-28 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040102-001 | METHAZOLAMIDE | 25MG | TABLET / ORAL | 1996-08-28 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040102-002 | METHAZOLAMIDE | 50MG | TABLET / ORAL | 1996-08-28 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040102-001 | METHAZOLAMIDE | 25MG | TABLET / ORAL | 1996-08-28 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040102-002 | METHAZOLAMIDE | 50MG | TABLET / ORAL | 1996-08-28 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040102-001 | METHAZOLAMIDE | 25MG | TABLET / ORAL | 1996-08-28 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040102-002 | METHAZOLAMIDE | 50MG | TABLET / ORAL | 1996-08-28 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040102-001 | METHAZOLAMIDE | 25MG | TABLET / ORAL | 1996-08-28 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040102-002 | METHAZOLAMIDE | 50MG | TABLET / ORAL | 1996-08-28 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040102-001 | METHAZOLAMIDE | 25MG | TABLET / ORAL | 1996-08-28 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040102-002 | METHAZOLAMIDE | 50MG | TABLET / ORAL | 1996-08-28 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A040102-001 | METHAZOLAMIDE | 25MG | TABLET / ORAL | 1996-08-28 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A040102-002 | METHAZOLAMIDE | 50MG | TABLET / ORAL | 1996-08-28 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040102-001 | METHAZOLAMIDE | 25MG | TABLET / ORAL | 1996-08-28 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040102-002 | METHAZOLAMIDE | 50MG | TABLET / ORAL | 1996-08-28 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040102-001 | METHAZOLAMIDE | 25MG | TABLET / ORAL | 1996-08-28 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040102-002 | METHAZOLAMIDE | 50MG | TABLET / ORAL | 1996-08-28 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040102-001 | METHAZOLAMIDE | 25MG | TABLET / ORAL | 1996-08-28 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040102-002 | METHAZOLAMIDE | 50MG | TABLET / ORAL | 1996-08-28 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A040102-001 | METHAZOLAMIDE | 25MG | TABLET / ORAL | 1996-08-28 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A040102-002 | METHAZOLAMIDE | 50MG | TABLET / ORAL | 1996-08-28 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040102-001 | METHAZOLAMIDE | 25MG | TABLET / ORAL | 1996-08-28 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040102-002 | METHAZOLAMIDE | 50MG | TABLET / ORAL | 1996-08-28 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A040102-001 | METHAZOLAMIDE | 25MG | TABLET / ORAL | 1996-08-28 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A040102-002 | METHAZOLAMIDE | 50MG | TABLET / ORAL | 1996-08-28 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A040102-001 | METHAZOLAMIDE | 25MG | TABLET / ORAL | 1996-08-28 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A040102-002 | METHAZOLAMIDE | 50MG | TABLET / ORAL | 1996-08-28 | 4b0b4de00fa7… | ||
| 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… |
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.
| 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 | Methazolamide METHAZOLAMIDE |
| Methazolamide | METHAZOLAMIDE | Bryant Ranch Prepack | 1698aa2d-a962-4bcc-8646-4fff532b645b | 2026-03-27 | Warnings, Adverse reactions | Methazolamide METHAZOLAMIDE |
| Methazolamide | METHAZOLAMIDE | Bryant Ranch Prepack | 504b695a-ac9e-4c71-8755-d31f1958a71c | 2026-03-25 | Warnings, Adverse reactions | Methazolamide METHAZOLAMIDE |
| Methazolamide | METHAZOLAMIDE | Bryant Ranch Prepack | 369e89a4-9898-4a9f-a316-17d0fce8a08b | 2026-03-25 | Warnings, Adverse reactions | Methazolamide METHAZOLAMIDE |
| Methazolamide | METHAZOLAMIDE | Ajanta Pharma USA Inc. | 879a3c78-24dd-41f9-8fce-5f3166b0e2f4 | 2026-02-10 | Warnings, Adverse reactions | Methazolamide METHAZOLAMIDE |
| Methazolamide | METHAZOLAMIDE | Golden State Medical Supply, Inc. | 723f830c-a534-55d1-e053-2a91aa0a403c | 2025-12-11 | Warnings, Adverse reactions | Methazolamide METHAZOLAMIDE |
| Methazolamide | METHAZOLAMIDE | ANI Pharmaceuticals, Inc. | c26c8834-961e-4c9c-9ad4-5db2d9419938 | 2025-11-26 | Warnings, Adverse reactions | Methazolamide METHAZOLAMIDE |
| Methazolamide | METHAZOLAMIDE | Bausch & Lomb Incorporated | 0c0ba5c7-c53e-4e29-a7ff-48fddc5a9258 | 2025-10-23 | Warnings, Adverse reactions | Methazolamide METHAZOLAMIDE |
| Methazolamide | METHAZOLAMIDE | Precision Dose, Inc. | 1e0e81c7-a328-4034-a6b3-4c83e9ac3a3e | 2023-12-04 | Warnings, Adverse reactions | Methazolamide METHAZOLAMIDE |
| Methazolamide | METHAZOLAMIDE | NorthStar Rx LLC | 042586b3-4d49-c5ae-e063-6394a90aaa7c | 2023-08-30 | Warnings, Adverse reactions | Methazolamide METHAZOLAMIDE |
| methazolamide | METHAZOLAMIDE | Padagis US LLC | 5e0795e1-d5c5-4b04-9bce-077bb8028023 | 2023-05-01 | Warnings, Adverse reactions | methazolamide METHAZOLAMIDE |
| METHAZOLAMIDE | METHAZOLAMIDE | Micro Labs Limited | 91a493f5-f8c3-4b64-a15e-b550d8631668 | 2020-02-17 | Warnings, Adverse reactions | METHAZOLAMIDE METHAZOLAMIDE |