Idiopathic Intracranial Hypertension

• FDA approval · 2026-01-08
  FDA Approved: ACETAZOLAMIDE — Supplemental Application (Strides Pharma Science Limited)

  FDA approved a supplemental application for acetazolamide from Strides Pharma Science Limited. The document indicates approval of a suppleme…

• FDA approval · 2025-05-30
  FDA Approved: ACETAZOLAMIDE — Original Application (Aurobindo Pharma Limited)

  FDA approved Aurobindo Pharma Limited's original application for a generic acetazolamide product.

• FDA approval · 2025-03-12
  FDA Approved: ACETAZOLAMIDE — Supplemental Application (Ajanta Pharma USA Inc.)

  FDA approved a supplemental application for acetazolamide submitted by Ajanta Pharma USA Inc.

• FDA approval · 2025-01-27
  FDA Approved: ACETAZOLAMIDE — Supplemental Application (Accord Healthcare Inc.)

  FDA approved a supplemental application for Acetazolamide from Accord Healthcare Inc. under an Abbreviated New Drug Application.

• FDA approval · 2024-11-26
  FDA Approved: ACETAZOLAMIDE EXTENDED-RELEASE — Supplemental Application (Micro Labs Limited)

  FDA approved a supplemental application from Micro Labs Limited for an extended-release formulation of acetazolamide.

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2024-07-26
  FDA Approved: ACETAZOLAMIDE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved a supplemental application for Acetazolamide under ANDA 202693, submitted by Heritage Pharmaceuticals d/b/a Avet Pharmaceutical…

• FDA approval · 2024-05-15
  FDA Approved: ACETAZOLAMIDE — Supplemental Application (Lifestar Pharma LLC)

  FDA has approved a supplemental application for acetazolamide submitted by Lifestar Pharma LLC.

• FDA approval · 2023-08-25
  FDA Approved: ACETAZOLAMIDE — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for acetazolamide sodium filed by Mylan Institutional LLC, approving the salt form of acetazolamide …

• FDA approval · 2023-08-16
  FDA Approved: ACETAZOLAMIDE — Supplemental Application (TRUPHARMA, LLC)

  FDA approved a supplemental application for acetazolamide from TRUPHARMA, LLC under ANDA 211372. This action updates the approval status of …

• FDA approval · 2023-08-16
  FDA Approved: ACETAZOLAMIDE — Supplemental Application (Eywa Pharma Inc)

  The FDA approved Eywa Pharma Inc's supplemental application for acetazolamide, enabling continued marketing of a generic acetazolamide produ…

• FDA approval · 2023-05-24
  FDA Approved: ACETAZOLAMIDE — Supplemental Application (Chartwell RX, LLC)

  The FDA approved a supplemental application for acetazolamide submitted by Chartwell RX, LLC.

• FDA approval · 2021-08-19
  FDA Approved: ACETAZOLAMIDE — Original Application (Advagen Pharma Ltd)

  FDA approved Advagen Pharma Ltd's generic acetazolamide under an original (ANDA) application, enabling marketing of a generic formulation of…

• FDA approval · 2019-10-17
  FDA Approved: ACETAZOLAMIDE — Original Application (ANI Pharmaceuticals, Inc.)

  The FDA approved ANI Pharmaceuticals' Original Application for acetazolamide, granting approval of a generic version.

• FDA approval · 2017-11-20
  FDA Approved: ACETAZOLAMIDE — Original Application (Strides Pharma Science Limited)

  FDA approved an original application for acetazolamide from Strides Pharma Science Limited, establishing a generic version of the drug. The …

• FDA approval · 2011-07-14
  FDA Approved: ACETAZOLAMIDE — Original Application (Westminster Pharmaceuticals, LLC)

  FDA approved the original ANDA for Acetazolamide from Westminster Pharmaceuticals, making a generic version of the carbonic anhydrase inhibi…

• FDA approval · 2008-12-10
  FDA Approved: ACETAZOLAMIDE — Original Application (XGen Pharmaceuticals DJB, Inc.)

  FDA approves a generic acetazolamide product (Diamox) from XGen Pharmaceuticals DJB, Inc. under an Original Application.