Pernicious Anemia

• FDA approval · 2025-01-10
  FDA Approved: CYANOCOBALAMIN — Supplemental Application (Plano Pharmaceuticals Inc.)

  The FDA approved a supplemental application for cyanocobalamin from Plano Pharmaceuticals Inc., indicating an approved modification to an ex…

• FDA approval · 2024-11-15
  FDA Approved: CYANOCOBALAMIN — Original Application (Meitheal Pharmaceuticals Inc.)

  The FDA approved Meitheal Pharmaceuticals' generic cyanocobalamin (Vitamin B12) under an original application, providing a generic option fo…

• FDA approval · 2024-07-10
  FDA Approved: CYANOCOBALAMIN — Original Application (BluePoint Laboratories)

  FDA approved Cyanocobalamin from BluePoint Laboratories via an Original Application. Indications include the treatment of Vitamin B12 defici…

• FDA approval · 2023-06-30
  FDA Approved: CYANOCOBALAMIN — Original Application (Lupin Pharmaceuticals,Inc.)

  FDA approved Lupin Pharmaceuticals' cyanocobalamin as an original generic application, enabling production of a generic vitamin B12 suppleme…

• FDA approval · 2022-11-15
  FDA Approved: CYANOCOBALAMIN — Original Application (Sagent Pharmaceuticals)

  FDA approved an original-application generic cyanocobalamin (Vitamin B12) from Sagent Pharmaceuticals.

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• FDA approval · 2022-10-14
  FDA Approved: CYANOCOBALAMIN — Supplemental Application (Plano Pharmaceuticals Inc.)

  FDA approved a supplemental application for cyanocobalamin from Plano Pharmaceuticals Inc., indicating changes to an already approved produc…

• FDA approval · 2022-04-15
  FDA Approved: CYANOCOBALAMIN — Original Application (SOLA Pharmaceuticals)

  FDA approved SOLA Pharmaceuticals' original application for CYANOCOBALAMIN (cyanocobalamin), a generic vitamin B12 product.

• FDA approval · 2022-04-15
  FDA Approved: CYANOCOBALAMIN — Original Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved Cyanocobalamin from Zydus Pharmaceuticals USA Inc. under an Original Application (ANDA214655).

• CLINICAL_TRIALS trial_result · 2021-03-08
  Clinical Trial Update: Megadose of Hydroxocobalamin for the Treatment of Pernicious Anemia [Phase 4]

  Phase 4 clinical trial evaluating megadose hydroxocobalamin for pernicious anemia has completed.

• FDA approval · 2020-12-08
  FDA Approved: CYANOCOBALAMIN — Original Application (AuroMedics Pharma LLC)

  The FDA approved a generic cyanocobalamin product from AuroMedics Pharma LLC under an Original Application (ANDA213874).

• FDA approval · 2020-10-21
  FDA Approved: CYANOCOBALAMIN — Supplemental Application (Somerset Therapeutics, LLC)

  The FDA approved a supplemental application for cyanocobalamin from Somerset Therapeutics, LLC under an ANDA.

• FDA approval · 2020-09-24
  FDA Approved: CYANOCOBALAMIN — Original Application (Plano Pharmaceuticals Inc.)

  FDA approved Plano Pharmaceuticals Inc.'s original application for cyanocobalamin (vitamin B12) as a generic drug.

• FDA approval · 2020-09-09
  FDA Approved: CYANOCOBALAMIN — Original Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved a generic cyanocobalamin product from Padagis Israel Pharmaceuticals Ltd under an original ANDA (212458).

• FDA approval · 2018-12-18
  FDA Approved: CYANOCOBALAMIN — Original Application (Vitruvias Therapeutics)

  FDA approved the original application for cyanocobalamin from Vitruvias Therapeutics, enabling a generic cyanocobalamin product to be market…

• FDA approval · 2018-12-18
  FDA Approved: CYANOCOBALAMIN — Original Application (Somerset Therapeutics, LLC)

  FDA approves cyanocobalamin (generic) from Somerset Therapeutics, LLC via Original Application (ANDA209429).

• FDA approval · 2018-12-07
  FDA Approved: NASCOBAL — Supplemental Application (ENDO USA, Inc.)

  FDA approved a supplemental application for NASCOBAL (cyanocobalamin) submitted by ENDO USA, Inc.

• FDA approval · 2016-04-25
  FDA Approved: NASCOBAL — Supplemental Application (ENDO USA, Inc.)

  FDA approved a supplemental application for NASCOBAL (cyanocobalamin) submitted by ENDO USA, Inc.

• FDA approval · 2015-12-11
  FDA Approved: CYANOCOBALAMIN — Original Application (Somerset Therapeutics, LLC)

  The FDA approved an original generic application for cyanocobalamin (vitamin B12) from Somerset Therapeutics, LLC.

• FDA label_change · 2015-06-17
  FDA Approved: NASCOBAL — Supplemental Application (ENDO USA, Inc.)

  FDA approves a supplemental application for NASCOBAL (cyanocobalamin) from ENDO USA, Inc., likely updating labeling.

• FDA approval · 2014-10-30
  FDA Approved: NASCOBAL — Supplemental Application (ENDO USA, Inc.)

  The FDA approved a supplemental application for NASCOBAL (cyanocobalamin) filed by ENDO USA, Inc. The action involves labeling/indication up…

• FDA approval · 2014-06-11
  FDA Approved: NASCOBAL — Supplemental Application (ENDO USA, Inc.)

  FDA approved a supplemental application for NASCOBAL (cyanocobalamin) submitted by ENDO USA, Inc., under NDA 021642. This action approves th…

• FDA label_change · 2014-06-06
  FDA Approved: NASCOBAL — Supplemental Application (ENDO USA, Inc.)

  The FDA approved a supplemental application for NASCOBAL (cyanocobalamin) submitted by ENDO USA, Inc. This action updates the drug's labelin…

• FDA approval · 2013-09-06
  FDA Approved: NASCOBAL — Supplemental Application (ENDO USA, Inc.)

  FDA approved a supplemental application for NASCOBAL (cyanocobalamin) submitted by ENDO USA, Inc.

• FDA label_change · 2011-12-08
  FDA Approved: NASCOBAL — Supplemental Application (ENDO USA, Inc.)

  FDA approved a supplemental application for NASCOBAL (cyanocobalamin) from ENDO USA, Inc., updating the product labeling for vitamin B12 def…