Tumor Lysis Syndrome

• FDA approval · 2025-06-13
  FDA Approved: ALLOPURINOL — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for Allopurinol from Zydus Lifesciences Limited.

• FDA approval · 2025-04-14
  FDA Approved: ALLOPURINOL — Original Application (Aurobindo Pharma Limited)

  FDA approved the original application for Allopurinol from Aurobindo Pharma Limited, authorizing a generic version of allopurinol.

• 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 · 2024-08-30
  FDA Approved: ALLOPURINOL — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Allopurinol from Camber Pharmaceuticals, Inc. under the ANDA program. This action constitutes a …

• FDA approval · 2024-04-03
  FDA Approved: ALLOPURINOL — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for Allopurinol from Actavis Pharma, Inc., authorizing changes to the product’s labeling.

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• 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 (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved a supplemental application for allopurinol from Heritage Pharmaceuticals (d/b/a Avet Pharmaceuticals) under ANDA204467. The app…

• 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 · 2024-01-29
  FDA Approved: ALLOPURINOL — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for Allopurinol from Sun Pharmaceutical Industries, Inc., indicating an approved update to the drug'…

• FDA approval · 2023-03-15
  FDA Approved: ALLOPURINOL — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Allopurinol from Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. under ANDA204…

• 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…

• FDA approval · 2022-03-07
  FDA Approved: ALLOPURINOL — Original Application (Harman Finochem Limited)

  FDA approves the original application for Allopurinol from Harman Finochem Limited.

• FDA approval · 2022-02-17
  FDA Approved: ALOPRIM — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for ALOPRIM (allopurinol) submitted by Mylan Institutional LLC.

• 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 · 2019-12-12
  FDA Approved: ELITEK — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approved a supplemental application for ELITEK (rasburicase) submitted by Sanofi-Aventis U.S. LLC.

• FDA approval · 2019-03-19
  FDA Approved: ALLOPURINOL — Supplemental Application (Chartwell RX, LLC)

  The FDA approved a supplemental application for allopurinol (generic) submitted by Chartwell RX, LLC.

• FDA approval · 2019-03-12
  FDA Approved: ALLOPURINOL — Original Application (Unichem Pharmaceuticals (USA), Inc.)

  The FDA approved Unichem Pharmaceuticals (USA), Inc.'s original application for Allopurinol, a generic drug used to treat gout and hyperuric…

• FDA approval · 2018-12-03
  FDA Approved: ALLOPURINOL — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for Allopurinol filed by Rising Pharma Holdings, Inc.

• FDA approval · 2017-09-14
  FDA Approved: ELITEK — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approved a supplemental application for ELITEK (rasburicase) submitted by Sanofi-Aventis U.S. LLC.

• 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 · 2016-07-28
  FDA Approved: ALLOPURINOL — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved an original (generic) application for allopurinol from Heritage Pharmaceuticals Inc. (d/b/a Avet Pharmaceuticals Inc.).

• FDA approval · 2016-06-13
  FDA Approved: ELITEK — Supplemental Application (Sanofi-Aventis U.S. LLC)

  The FDA approved a supplemental application for ELITEK (rasburicase) submitted by Sanofi-Aventis U.S. LLC.

• FDA approval · 2015-05-22
  FDA Approved: ELITEK — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approves a supplemental application for ELITEK (rasburicase) filed by Sanofi-Aventis U.S. LLC.