FDA.reportPublic FDA data

Application 012945

Type
NDA
Sponsor
TEVA BRANDED PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DIAMOXACETAZOLAMIDECAPSULE, EXTENDED RELEASE;ORAL500MGYesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N012945-001DIAMOXACETAZOLAMIDE500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD, Approved before 1982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.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N012945-001DIAMOX500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N012945-001DIAMOX500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N012945-001DIAMOX500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD, Approved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N012945-001DIAMOX500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD, Approved before 1982a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-07-19 19:46 UTC2019-07N012945-001AB1ea99ee380514…

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 3 · 49 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcetazolamideACETAZOLAMIDEStrides Pharma Science Limited4813b9dd-5f58-44bb-ad64-cdb3318280802026-08-19Warnings, Adverse reactionsName fallback
generic name: ACETAZOLAMIDE
AcetazolamideACETAZOLAMIDEPD-Rx Pharmaceuticals, Inc.268db224-d5db-457c-86bc-972c9fe079172026-07-07Warnings, Adverse reactionsName fallback
generic name: ACETAZOLAMIDE
acetazolamideACETAZOLAMIDEMajor Pharmaceuticals37135ba5-63fd-427f-9b4a-8b7d1009bbca2026-05-28Warnings, Adverse reactionsName fallback
generic name: ACETAZOLAMIDE
AcetazolamideACETAZOLAMIDEA-S Medication Solutionsc5acf531-ba55-47b7-88db-e5da0206ebf12026-05-22Warnings, Adverse reactionsName fallback
generic name: ACETAZOLAMIDE
AcetazolamideACETAZOLAMIDEBryant Ranch Prepack71f1fbbb-428e-4bf7-bc20-2946c1079bd32026-05-20Warnings, Adverse reactionsName fallback
generic name: ACETAZOLAMIDE
acetazolamideACETAZOLAMIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.0700a910-79aa-4431-aecf-637fe14fcae82026-05-12Warnings, Adverse reactionsName fallback
generic name: ACETAZOLAMIDE
acetazolamideACETAZOLAMIDEA-S Medication Solutions07fd0bde-8f7c-47d2-9e81-2c1eee259fa62026-05-01Warnings, Adverse reactionsName fallback
generic name: ACETAZOLAMIDE
AcetazolamideACETAZOLAMIDEREMEDYREPACK INC.fb2cf8fe-da81-445e-a18b-9aa9ced1d34a2026-04-28Warnings, Adverse reactionsName fallback
generic name: ACETAZOLAMIDE
AcetazolamideACETAZOLAMIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.4dd56001-4941-4ff0-9f30-02a1bcc4fe7e2026-04-10Warnings, Adverse reactionsName fallback
generic name: ACETAZOLAMIDE
acetazolamideACETAZOLAMIDEBryant Ranch Prepack0d903375-c583-4362-9f8a-f7b74ce01e0b2026-04-09Warnings, Adverse reactionsName fallback
generic name: ACETAZOLAMIDE
AcetazolamideACETAZOLAMIDEBryant Ranch Prepack9af15152-d46f-4bc3-a16e-b70a472bc52a2026-03-23Warnings, Adverse reactionsName fallback
generic name: ACETAZOLAMIDE
AcetazolamideACETAZOLAMIDEBryant Ranch Prepack84a582a9-c7e5-4159-a5eb-a47a96b4afc02026-03-23Warnings, Adverse reactionsName fallback
generic name: ACETAZOLAMIDE
AcetazolamideACETAZOLAMIDEBryant Ranch Prepackf7227cc5-0a80-47df-baf8-09f1b22b187e2026-03-20Warnings, Adverse reactionsName fallback
generic name: ACETAZOLAMIDE
AcetazolamideACETAZOLAMIDELifestar Pharma LLC0913db35-3f08-4d82-8394-486bd9a487c42026-03-17Warnings, Adverse reactionsName fallback
generic name: ACETAZOLAMIDE
AcetazolamideACETAZOLAMIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.33d912ea-9e1c-49eb-bd93-f0b1b2da67b62026-02-26Warnings, Adverse reactionsName fallback
generic name: ACETAZOLAMIDE
acetazolamideACETAZOLAMIDEAvKAREd6fba129-ac6e-4d04-bd09-8470be4e7ecc2026-02-24Warnings, Adverse reactionsName fallback
generic name: ACETAZOLAMIDE
AcetazolamideACETAZOLAMIDEWestminster Pharmaceuticals, LLC417b1df2-63bc-473c-9e02-5f93dd45554d2026-02-17Warnings, Adverse reactionsName fallback
generic name: ACETAZOLAMIDE
acetaZOLAMIDEACETAZOLAMIDEA-S Medication Solutionsb339843f-0324-4996-88a0-0619fd6f867b2026-02-13Warnings, Adverse reactionsName fallback
generic name: ACETAZOLAMIDE
AcetazolamideACETAZOLAMIDEMarlex Pharmaceuticals, Inc.4a03f35d-bfcb-77ff-e063-6294a90a4f062026-02-01Warnings, Adverse reactionsName fallback
generic name: ACETAZOLAMIDE
AcetazolamideACETAZOLAMIDEANI Pharmaceuticals, Inc.bde94a48-05d0-45a0-a589-ec05b7d165322026-01-23Warnings, Adverse reactionsName fallback
generic name: ACETAZOLAMIDE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0555-0513AcetazolamideAcetazolamideTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
51285-754Diamox SequelsAcetazolamideTeva Women's Health, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79712SUPPL 2024-09-24
79696SUPPL 2024-09-23
71083SUPPL2022-05-17
71076SUPPL2022-05-16
20040SUPPL2015-01-28
20039SUPPL2015-01-28
33098SUPPL2005-03-18
12043SUPPL2005-03-18
10828SUPPL2005-03-18
349SUPPL2005-03-18