Pericarditis

• FDA approval · 2026-02-17
  FDA Approved: COLCHICINE — Original Application (Micro Labs Limited)

  FDA approved the original ANDA for colchicine (Colchicine) from Micro Labs Limited, enabling a generic version of the drug. The approval con…

• FDA approval · 2025-07-01
  FDA Approved: COLCHICINE — Supplemental Application (Par Health USA, LLC)

  FDA approved a supplemental application for Colchicine from Par Health USA, LLC. The action likely updates the product’s labeling or indicat…

• FDA approval · 2025-03-14
  FDA Approved: COLCHICINE — Supplemental Application (Par Health USA, LLC)

  FDA approved a supplemental application for colchicine submitted by Par Health USA, LLC. The action pertains to the generic colchicine produ…

• FDA approval · 2024-12-12
  FDA Approved: COLCHICINE — Supplemental Application (Granules Pharmaceutical Inc.)

  The FDA approved a supplemental application for Colchicine from Granules Pharmaceutical Inc., updating the approved Colchicine product.

• FDA approval · 2024-05-16
  FDA Approved: MITIGARE — Supplemental Application (Hikma Specialty USA Inc.)

  FDA approved a supplemental application for Mitigare (colchicine) submitted by Hikma Specialty USA Inc. The action updates the product label…

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• FDA approval · 2024-04-29
  FDA Approved: COLCHICINE — Original Application (Granules Pharmaceutical Inc.)

  FDA approved an Original Application for a generic colchicine product by Granules Pharmaceutical Inc., establishing a generic option for col…

• FDA approval · 2024-04-29
  FDA Approved: COLCHICINE — Original Application (Camber Pharmaceuticals, Inc.)

  The FDA approved Camber Pharmaceuticals’ generic colchicine under an original ANDA, authorizing its marketing as a generic product.

• FDA approval · 2024-04-29
  FDA Approved: COLCHICINE — Original Application (Aurobindo Pharma Limited)

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

• FDA approval · 2023-06-16
  FDA Approved: LODOCO — Original Application (AGEPHA Pharma USA, LLC)

  FDA approved LODOCO (colchicine tablets 0.5 mg) under an original NDA from AGEPHA Pharma USA, LLC.

• FDA approval · 2022-03-10
  FDA Approved: COLCHICINE — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved an original ANDA for colchicine from Heritage Pharmaceuticals (d/b/a Avet Pharmaceuticals Inc.), providing a generic version of…

• FDA approval · 2021-08-13
  FDA Approved: COLCHICINE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' original ANDA for colchicine, authorizing a generic version of the drug.

• FDA approval · 2021-08-12
  FDA Approved: COLCHICINE — Original Application (Par Health USA, LLC)

  FDA approved the original application for colchicine (generic) from Par Health USA, LLC.

• FDA approval · 2020-03-30
  FDA Approved: COLCHICINE — Supplemental Application (Dr.Reddys Laboratories, Inc.)

  FDA approved a supplemental application for Colchicine submitted by Dr. Reddy's Laboratories, Inc.

• FDA approval · 2019-11-14
  FDA Approved: COLCHICINE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for COLCHICINE from Zydus Lifesciences Limited. This indicates a supplemental approval for this gene…

• FDA approval · 2019-09-16
  FDA Approved: COLCHICINE — Original Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a generic colchicine product from Mylan Pharmaceuticals Inc. under an original ANDA (ANDA209470).

• FDA approval · 2019-02-08
  FDA Approved: COLCHICINE — Original Application (Ascend Laboratories, LLC)

  FDA approved Ascend Laboratories, LLC's original ANDA application for Colchicine, making a generic colchicine product available in the U.S.

• FDA approval · 2018-11-29
  FDA Approved: COLCHICINE — Original Application (Par Health USA, LLC)

  The FDA approved an original ANDA for colchicine from Par Health USA, LLC, enabling the marketing of a generic colchicine product. This repr…

• FDA approval · 2018-11-16
  FDA Approved: MITIGARE — Supplemental Application (Hikma Specialty USA Inc.)

  The FDA approved a supplemental application for MITIGARE (colchicine) filed by Hikma Specialty USA Inc.

• FDA approval · 2016-12-22
  FDA Approved: COLCRYS — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for COLCRYS (colchicine) from Takeda Pharmaceuticals America, Inc., indicating changes to its labeli…

• FDA approval · 2016-01-25
  FDA Approved: COLCRYS — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for COLCRYS (colchicine) filed by Takeda Pharmaceuticals America, expanding or updating the drug…

• FDA approval · 2015-12-17
  FDA Approved: COLCRYS — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for COLCRYS (colchicine) submitted by Takeda Pharmaceuticals America, Inc.

• FDA approval · 2014-09-26
  FDA Approved: MITIGARE — Original Application (Hikma Specialty USA Inc.)

  FDA approved the Mitigare brand of colchicine (Hikma Specialty USA Inc.) through an Original Application. This establishes a labeled colchic…

• FDA approval · 2014-08-14
  FDA Approved: COLCRYS — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approves a supplemental application for COLCRYS (colchicine) submitted by Takeda Pharmaceuticals America, Inc. The supplemental approval…

• FDA approval · 2010-09-30
  FDA Approved: ARCALYST — Supplemental Application (Kiniksa Pharmaceuticals (UK), Ltd.)

  The FDA approved a supplemental application for ARCALYST (rilonacept) by Kiniksa Pharmaceuticals (UK), Ltd., updating the existing approval.

• FDA approval · 2010-04-29
  FDA Approved: COLCRYS — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for Colcrys (colchicine) submitted by Takeda Pharmaceuticals America, Inc.