Hypocalcemia

• FDA approval · 2025-06-09
  FDA Approved: CALCIUM GLUCONATE — Supplemental Application (Amneal Pharmaceuticals Private Limited)

  FDA approved a supplemental application for calcium gluconate from Amneal Pharmaceuticals Private Limited.

• FDA approval · 2024-11-27
  FDA Approved: CALCIUM CHLORIDE — Original Application (Dr. Reddy's Laboratories Inc.)

  FDA approved a generic calcium chloride product from Dr. Reddy's Laboratories Inc. under an Original Application (ANDA).

• FDA approval · 2022-10-17
  FDA Approved: CALCIUM GLUCONATE — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for CALCIUM GLUCONATE from Fresenius Kabi USA, LLC.

• FDA approval · 2021-06-17
  FDA Approved: CALCIUM GLUCONATE — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for Calcium Gluconate submitted by Fresenius Kabi USA, LLC.

• FDA approval · 2019-02-21
  FDA Approved: CALCITRIOL — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approves a generic calcitriol product from Sun Pharmaceutical Industries under an original ANDA, enabling another generic calcitriol opt…

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• FDA approval · 2017-06-15
  FDA Approved: CALCIUM GLUCONATE — Original Application (Fresenius Kabi USA, LLC)

  The FDA approved Fresenius Kabi USA, LLC's calcium gluconate product under an original NDA.

• FDA approval · 2017-06-14
  FDA Approved: CALCITRIOL — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal Pharmaceuticals' generic calcitriol (1,25-dihydroxyvitamin D3). The approval is an Original Application for this generic…

• FDA approval · 2016-06-17
  FDA Approved: RAYALDEE — Original Application (OPKO Pharmaceuticals LLC)

  The FDA approved RAYALDEE (calcifediol) from OPKO Pharmaceuticals as a new drug for adults with stage 3–4 chronic kidney disease and hypocal…

• FDA approval · 2014-12-12
  FDA Approved: CALCITRIOL — Original Application (Chartwell RX, LLC)

  FDA approved Calcitriol capsules (0.25 mcg and 0.5 mcg) from Chartwell RX, LLC through an Original Application, granting a generic version o…

• FDA approval · 2013-05-24
  FDA Approved: CALCITRIOL — Original Application (BIONPHARMA INC.)

  FDA approved the original ANDA application for Calcitriol from BIONPHARMA INC., a generic version of the active vitamin D3 analog.

• FDA approval · 2013-05-15
  FDA Approved: CALCITRIOL — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for CALCITRIOL (calcitriol) from Sun Pharmaceutical Industries, Inc., updating the product’s reg…

• FDA approval · 2010-08-03
  FDA Approved: VITAMIN D — Original Application (Strides Pharma Science Limited)

  FDA approves Strides Pharma Science Limited's generic vitamin D product ergocalciferol under an Original Application (ANDA 090455).

• FDA approval · 2006-07-03
  FDA Approved: CALCITRIOL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for Calcitriol from Hikma Pharmaceuticals USA Inc., updating the approval status for this generi…