Mountain Sickness

• FDA approval · 2026-04-02
  FDA Approved: ACETAZOLAMIDE — Supplemental Application (Lifestar Pharma LLC)

  FDA approved a supplemental application for acetazolamide filed by Lifestar Pharma LLC under the ANDA program. The document does not specify…

• FDA approval · 2026-01-12
  FDA Approved: ACETAZOLAMIDE — Supplemental Application (Ajanta Pharma USA Inc.)

  FDA approved Ajanta Pharma USA Inc.'s supplemental application for acetazolamide. This action approves changes to the product associated wit…

• 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 · 2025-06-17
  FDA Approved: ACETAZOLAMIDE — Original Application (Sagent Pharmaceuticals)

  FDA approved Sagent Pharmaceuticals' Original Application for Acetazolamide, including Acetazolamide and Acetazolamide Sodium formulations.

• 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.

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• FDA approval · 2025-03-13
  FDA Approved: ACETAZOLAMIDE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved a supplemental application for acetazolamide from ANI Pharmaceuticals, Inc., under ANDA 210588, indicating approval of a change…

• 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 · 2024-12-12
  FDA Approved: ACETAZOLAMIDE — Supplemental Application (Alembic Pharmaceuticals Inc.)

  FDA approved a supplemental application for Acetazolamide from Alembic Pharmaceuticals Inc., indicating a supplemental approval for this gen…

• 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 · 2023-09-11
  FDA Approved: ACETAZOLAMIDE — Original Application (Ajanta Pharma USA Inc.)

  FDA approved Ajanta Pharma USA Inc.'s original application for acetazolamide (generic).

• 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 · 2023-05-19
  FDA Approved: ACETAZOLAMIDE — Supplemental Application (Accord Healthcare Inc.)

  FDA approved a supplemental application for Acetazolamide from Accord Healthcare Inc., a generic drug.

• FDA approval · 2023-05-09
  FDA Approved: ACETAZOLAMIDE — Original Application (Marlex Pharmaceuticals, Inc.)

  FDA approved acetazolamide as an original ANDA from Marlex Pharmaceuticals, providing a generic version of the carbonic anhydrase inhibitor.…

• FDA approval · 2023-04-04
  FDA Approved: ACETAZOLAMIDE — Original Application (Zydus Lifesciences Limited)

  FDA approved a generic acetazolamide product from Zydus Lifesciences Limited under an Original Application (ANDA211069).

• 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 · 2021-02-22
  FDA Approved: ACETAZOLAMIDE — Original Application (TRUPHARMA, LLC)

  The FDA approved an original ANDA for Acetazolamide, a generic version manufactured by TRUPHARMA, LLC.

• FDA approval · 2020-10-01
  FDA Approved: ACETAZOLAMIDE EXTENDED-RELEASE — Original Application (Micro Labs Limited)

  FDA approved an acetazolamide extended-release product as an original application from Micro Labs Limited.

• FDA approval · 2019-10-18
  FDA Approved: ACETAZOLAMIDE — Original Application (Eywa Pharma Inc)

  FDA approved acetazolamide from Eywa Pharma Inc under an original application (ANDA 211556), making a generic version of the drug available.

• FDA approval · 2018-10-18
  FDA Approved: ACETAZOLAMIDE — Original Application (Accord Healthcare Inc.)

  FDA approved Accord Healthcare Inc.'s Original Application for acetazolamide, confirming a generic version of the drug. The approval allows …

• 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 …