Application 012945
- Type
- NDA
- Sponsor
- TEVA BRANDED PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DIAMOX | ACETAZOLAMIDE | CAPSULE, EXTENDED RELEASE;ORAL | 500MG | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N012945-001 | DIAMOX | ACETAZOLAMIDE | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N012945-001 | DIAMOX | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N012945-001 | DIAMOX | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N012945-001 | DIAMOX | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N012945-001 | DIAMOX | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N012945-001 | DIAMOX | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N012945-001 | DIAMOX | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N012945-001 | DIAMOX | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N012945-001 | DIAMOX | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N012945-001 | DIAMOX | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N012945-001 | DIAMOX | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N012945-001 | DIAMOX | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N012945-001 | DIAMOX | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N012945-001 | DIAMOX | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N012945-001 | DIAMOX | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N012945-001 | DIAMOX | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N012945-001 | DIAMOX | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N012945-001 | DIAMOX | 500MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N012945-001 | DIAMOX | 500MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N012945-001 | DIAMOX | 500MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N012945-001 | DIAMOX | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N012945-001 | DIAMOX | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N012945-001 | DIAMOX | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N012945-001 | DIAMOX | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N012945-001 | DIAMOX | 500MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N012945-001 | DIAMOX | 500MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N012945-001 | DIAMOX | 500MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N012945-001 | DIAMOX | 500MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N012945-001 | DIAMOX | 500MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS, Approved before 1982 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N012945-001 | DIAMOX | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N012945-001 | DIAMOX | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | N012945-001 | DIAMOX | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N012945-001 | DIAMOX | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N012945-001 | DIAMOX | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N012945-001 | DIAMOX | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N012945-001 | DIAMOX | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | N012945-001 | DIAMOX | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N012945-001 | DIAMOX | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N012945-001 | DIAMOX | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N012945-001 | DIAMOX | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | N012945-001 | DIAMOX | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | e64feba35796… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-07-19 19:46 UTC | 2019-07 | N012945-001 | AB | 1 | ea99ee380514… |
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 |
|---|---|---|---|---|---|---|
| Acetazolamide | ACETAZOLAMIDE | Strides Pharma Science Limited | 4813b9dd-5f58-44bb-ad64-cdb331828080 | 2026-08-19 | Warnings, Adverse reactions | ACETAZOLAMIDE |
| Acetazolamide | ACETAZOLAMIDE | PD-Rx Pharmaceuticals, Inc. | 268db224-d5db-457c-86bc-972c9fe07917 | 2026-07-07 | Warnings, Adverse reactions | ACETAZOLAMIDE |
| acetazolamide | ACETAZOLAMIDE | Major Pharmaceuticals | 37135ba5-63fd-427f-9b4a-8b7d1009bbca | 2026-05-28 | Warnings, Adverse reactions | ACETAZOLAMIDE |
| Acetazolamide | ACETAZOLAMIDE | A-S Medication Solutions | c5acf531-ba55-47b7-88db-e5da0206ebf1 | 2026-05-22 | Warnings, Adverse reactions | ACETAZOLAMIDE |
| Acetazolamide | ACETAZOLAMIDE | Bryant Ranch Prepack | 71f1fbbb-428e-4bf7-bc20-2946c1079bd3 | 2026-05-20 | Warnings, Adverse reactions | ACETAZOLAMIDE |
| acetazolamide | ACETAZOLAMIDE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 0700a910-79aa-4431-aecf-637fe14fcae8 | 2026-05-12 | Warnings, Adverse reactions | ACETAZOLAMIDE |
| acetazolamide | ACETAZOLAMIDE | A-S Medication Solutions | 07fd0bde-8f7c-47d2-9e81-2c1eee259fa6 | 2026-05-01 | Warnings, Adverse reactions | ACETAZOLAMIDE |
| Acetazolamide | ACETAZOLAMIDE | REMEDYREPACK INC. | fb2cf8fe-da81-445e-a18b-9aa9ced1d34a | 2026-04-28 | Warnings, Adverse reactions | ACETAZOLAMIDE |
| Acetazolamide | ACETAZOLAMIDE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 4dd56001-4941-4ff0-9f30-02a1bcc4fe7e | 2026-04-10 | Warnings, Adverse reactions | ACETAZOLAMIDE |
| acetazolamide | ACETAZOLAMIDE | Bryant Ranch Prepack | 0d903375-c583-4362-9f8a-f7b74ce01e0b | 2026-04-09 | Warnings, Adverse reactions | ACETAZOLAMIDE |
| Acetazolamide | ACETAZOLAMIDE | Bryant Ranch Prepack | 9af15152-d46f-4bc3-a16e-b70a472bc52a | 2026-03-23 | Warnings, Adverse reactions | ACETAZOLAMIDE |
| Acetazolamide | ACETAZOLAMIDE | Bryant Ranch Prepack | 84a582a9-c7e5-4159-a5eb-a47a96b4afc0 | 2026-03-23 | Warnings, Adverse reactions | ACETAZOLAMIDE |
| Acetazolamide | ACETAZOLAMIDE | Bryant Ranch Prepack | f7227cc5-0a80-47df-baf8-09f1b22b187e | 2026-03-20 | Warnings, Adverse reactions | ACETAZOLAMIDE |
| Acetazolamide | ACETAZOLAMIDE | Lifestar Pharma LLC | 0913db35-3f08-4d82-8394-486bd9a487c4 | 2026-03-17 | Warnings, Adverse reactions | ACETAZOLAMIDE |
| Acetazolamide | ACETAZOLAMIDE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 33d912ea-9e1c-49eb-bd93-f0b1b2da67b6 | 2026-02-26 | Warnings, Adverse reactions | ACETAZOLAMIDE |
| acetazolamide | ACETAZOLAMIDE | AvKARE | d6fba129-ac6e-4d04-bd09-8470be4e7ecc | 2026-02-24 | Warnings, Adverse reactions | ACETAZOLAMIDE |
| Acetazolamide | ACETAZOLAMIDE | Westminster Pharmaceuticals, LLC | 417b1df2-63bc-473c-9e02-5f93dd45554d | 2026-02-17 | Warnings, Adverse reactions | ACETAZOLAMIDE |
| acetaZOLAMIDE | ACETAZOLAMIDE | A-S Medication Solutions | b339843f-0324-4996-88a0-0619fd6f867b | 2026-02-13 | Warnings, Adverse reactions | ACETAZOLAMIDE |
| Acetazolamide | ACETAZOLAMIDE | Marlex Pharmaceuticals, Inc. | 4a03f35d-bfcb-77ff-e063-6294a90a4f06 | 2026-02-01 | Warnings, Adverse reactions | ACETAZOLAMIDE |
| Acetazolamide | ACETAZOLAMIDE | ANI Pharmaceuticals, Inc. | bde94a48-05d0-45a0-a589-ec05b7d16532 | 2026-01-23 | Warnings, Adverse reactions | ACETAZOLAMIDE |