Uric Acid Nephrolithiasis

• FDA approval · 2025-02-11
  FDA Approved: ALLOPURINOL — Supplemental Application (Accord Healthcare Inc.)

  FDA approved a supplemental application for Allopurinol from Accord Healthcare Inc., indicating an additional approval for the generic produ…

• FDA approval · 2024-02-16
  FDA Approved: ALLOPURINOL — Supplemental Application (Par Health USA, LLC)

  The FDA approved a supplemental application for Allopurinol submitted by Par Health USA, LLC.

• FDA approval · 2024-02-05
  FDA Approved: ALLOPURINOL — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for ALLOPURINOL (Allopurinol) submitted by Zydus Lifesciences Limited, authorizing changes to the ap…

• FDA approval · 2022-08-08
  FDA Approved: ALLOPURINOL — Supplemental Application (Gland Pharma Limited)

  FDA approved a supplemental application from Gland Pharma Limited for Allopurinol, enabling the marketing of a generic Allopurinol product u…

• FDA approval · 2022-08-04
  FDA Approved: ALLOPURINOL — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for allopurinol submitted by Rising Pharma Holdings, Inc. This action authorizes a post-approval…

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• FDA approval · 2022-01-26
  FDA Approved: ALLOPURINOL — Original Application (Gland Pharma Limited)

  FDA approved the original application for allopurinol from Gland Pharma Limited, enabling a generic version in the United States.

• FDA approval · 2020-08-28
  FDA Approved: ALOPRIM — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for ALOPRIM (allopurinol) submitted by Mylan Institutional LLC. The action relates to updates in the…

• FDA approval · 2016-09-09
  FDA Approved: ALLOPURINOL SODIUM — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Allopurinol Sodium (generic) from Hikma Pharmaceuticals USA Inc. under an ANDA.

• FDA approval · 2015-05-13
  FDA Approved: ALOPRIM — Supplemental Application (Mylan Institutional LLC)

  The FDA approved a supplemental application for ALOPRIM (allopurinol) submitted by Mylan Institutional LLC, resulting in updated labeling.

• FDA approval · 2013-05-06
  FDA Approved: ALLOPURINOL — Original Application (Accord Healthcare Inc.)

  FDA approved Accord Healthcare's original application for the generic drug allopurinol. Allopurinol is used to treat gout and to lower uric …