Esophageal Variceal Bleeding

• FDA approval · 2024-07-09
  FDA Approved: OCTREOTIDE ACETATE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  The FDA approved a supplemental application for octreotide acetate (ANDA 203765) submitted by Heritage Pharmaceuticals d/b/a Avet Pharmaceut…

• FDA approval · 2024-02-09
  FDA Approved: VASOPRESSIN — Original Application (Sagent Pharmaceuticals)

  FDA approved the original application for a generic vasopressin product from Sagent Pharmaceuticals.

• FDA approval · 2023-06-30
  FDA Approved: OCTREOTIDE — Supplemental Application (Fresenius Kabi USA, LLC)

  The FDA approved a supplemental application for octreotide acetate filed by Fresenius Kabi USA, LLC.

• FDA approval · 2023-06-22
  FDA Approved: OCTREOTIDE ACETATE — Original Application (Gland Pharma Limited)

  FDA approved OCTREOTIDE ACETATE from Gland Pharma Limited via an Original Application (ANDA 216839), establishing a generic version of octre…

• FDA approval · 2023-06-13
  FDA Approved: OCTREOTIDE ACETATE — Original Application (Gland Pharma Limited)

  FDA approved the original application for octreotide acetate, a generic product from Gland Pharma Limited. Octreotide acetate is indicated f…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2023-02-21
  FDA Approved: OCTREOTIDE ACETATE — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for octreotide acetate by Mylan Institutional LLC under ANDA 079198, granting a supplemental approva…

• FDA approval · 2023-02-21
  FDA Approved: OCTREOTIDE ACETATE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved a supplemental application to Heritage Pharmaceuticals (Avet) for octreotide acetate, a generic product, under an ANDA.

• FDA approval · 2022-06-07
  FDA Approved: NADOLOL — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for Nadolol submitted by Aurobindo Pharma Limited under the ANDA, approving updated labeling for…

• FDA approval · 2017-07-10
  FDA Approved: OCTREOTIDE ACETATE — Supplemental Application (Sagent Pharmaceuticals)

  FDA approves a supplemental application for Octreotide Acetate submitted by Sagent Pharmaceuticals.

• FDA approval · 2017-06-27
  FDA Approved: OCTREOTIDE ACETATE — Supplemental Application (Meitheal Pharmaceuticals, Inc.)

  The FDA approved Meitheal Pharmaceuticals' supplemental application for octreotide acetate. This approval authorizes a generic octreotide ac…

• FDA approval · 2017-06-02
  FDA Approved: NADOLOL — Original Application (Amneal Pharmaceuticals NY LLC)

  The FDA approved Amneal's original application for a generic nadolol, a non-selective beta-blocker used to treat hypertension and to prevent…

• FDA approval · 2015-09-16
  FDA Approved: NADOLOL — Original Application (Aurobindo Pharma Limited)

  FDA approved Nadolol tablets as a generic drug under an Original Application (ANDA 201893) from Aurobindo Pharma Limited. This approval make…

• FDA approval · 2013-11-12
  FDA Approved: OCTREOTIDE ACETATE — Original Application (Sagent Pharmaceuticals)

  FDA approved Sagent Pharmaceuticals' Original Application for octreotide acetate injectable, a generic form of octreotide. It is approved fo…

• FDA approval · 2013-05-23
  FDA Approved: OCTREOTIDE ACETATE — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for Octreotide acetate submitted by Mylan Institutional LLC.

• FDA approval · 2012-06-28
  FDA Approved: OCTREOTIDE ACETATE — Supplemental Application (Meitheal Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for octreotide acetate from Meitheal Pharmaceuticals, authorizing a generic version of the drug.…

• FDA approval · 2011-02-10
  FDA Approved: OCTREOTIDE ACETATE — Original Application (Mylan Institutional LLC)

  The FDA approved the original ANDA for octreotide acetate from Mylan Institutional LLC. This marks the generic approval for this product.

• FDA approval · 2009-03-03
  FDA Approved: OCTREOTIDE ACETATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Octreotide acetate from Hikma Pharmaceuticals USA Inc., updating the regulatory status of the ge…

• FDA approval · 2009-03-03
  FDA Approved: OCTREOTIDE ACETATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for octreotide acetate submitted by Hikma Pharmaceuticals USA Inc., under the ANDA pathway.