Zollinger-ellison Syndrome

• FDA approval · 2020-06-23
  FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Civica, Inc.)

  The FDA approved a supplemental application for pantoprazole sodium submitted by Civica, Inc. with this action representing an approved supp…

• FDA approval · 2020-06-02
  FDA Approved: ESOMEPRAZOLE MAGNESIUM — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' esomeprazole magnesium as a generic product (Original Application), expanding access to a proton pump i…

• FDA approval · 2020-06-02
  FDA Approved: ESOMEPRAZOLE MAGNESIUM — Original Application (Allegiant Health)

  FDA approved Allegiant Health's esomeprazole magnesium delayed-release capsule as an original ANDA, providing a generic proton pump inhibito…

• FDA approval · 2020-05-04
  FDA Approved: ESOMEPRAZOLE — Original Application (INNOVUS PHARMACEUTICALS, INC.)

  FDA approved Innovus Pharmaceuticals' original application for esomeprazole magnesium (Esomeprazole), a generic formulation.

• FDA approval · 2020-04-20
  FDA Approved: ESOMEPRAZOLE MAGNESIUM — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for esomeprazole magnesium (Ascend Laboratories) to bring a generic product to market.

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• FDA approval · 2020-04-01
  FDA Approved: ESOMEPRAZOLE SODIUM — Original Application (Gland Pharma Limited)

  FDA approved the original application for esomeprazole sodium (generic) from Gland Pharma Limited, enabling its marketing in the United Stat…

• FDA approval · 2020-03-23
  FDA Approved: ESOMEPRAZOLE MAGNESIUM — Original Application (Cipla USA Inc.)

  The FDA approved Cipla USA Inc.'s original application for esomeprazole magnesium, a generic proton pump inhibitor.

• FDA approval · 2020-03-23
  FDA Approved: ESOMEPRAZOLE MAGNESIUM — Original Application (Cipla USA Inc.)

  The FDA approved Cipla USA Inc.'s Esomeprazole Magnesium as a generic version of esomeprazole under an Original Application (ANDA).

• FDA approval · 2020-03-03
  FDA Approved: LANSOPRAZOLE — Supplemental Application (Lifestar Pharma LLC.)

  FDA approves a supplemental application to allow Lifestar Pharma LLC to market a generic version of lansoprazole.

• FDA label_change · 2020-01-07
  FDA Approved: FAMOTIDINE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA notes a supplemental application for famotidine by Lupin Pharmaceuticals, likely involving labeling changes for the drug.

• FDA approval · 2019-11-14
  FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for pantoprazole sodium from Torrent Pharmaceuticals Limited.

• FDA approval · 2019-11-14
  FDA Approved: PANTOPRAZOLE — Supplemental Application (NorthStar RxLLC)

  FDA approved a Supplemental Application for Pantoprazole from NorthStar RxLLC, indicating an approved revision or addition to this generic p…

• FDA approval · 2019-10-22
  FDA Approved: FAMOTIDINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for famotidine by Aurobindo Pharma Limited under an ANDA, extending approval to include this manufac…

• FDA approval · 2019-09-16
  FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for pantoprazole sodium from Amneal Pharmaceuticals LLC.

• FDA approval · 2019-09-11
  FDA Approved: ZANTAC 360 — Supplemental Application (Chattem, Inc.)

  The FDA approved a supplemental application for ZANTAC 360 (famotidine) from Chattem, Inc., updating the product under an approved supplemen…

• FDA approval · 2019-08-19
  FDA Approved: PANTOPRAZOLE SODIUM — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Pantoprazole Sodium as an original generic application from Sun Pharmaceutical Industries, Inc.

• FDA approval · 2019-07-01
  FDA Approved: LANSOPRAZOLE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for lansoprazole from Teva Pharmaceuticals USA, Inc. for the generic product under the ANDA process.

• FDA approval · 2019-05-10
  FDA Approved: ESOMEPRAZOLE MAGNESIUM — Original Application (Glenmark Pharmaceuticals Inc., USA)

  The FDA approved Glenmark's original generic application for esomeprazole magnesium, authorizing its use as a proton pump inhibitor. The pro…

• FDA approval · 2019-04-25
  FDA Approved: PROTONIX I.V. — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)

  The FDA approved a supplemental application to add intravenous pantoprazole sodium (PROTONIX I.V.) as a new dosage form for the drug, expand…

• FDA approval · 2019-04-04
  FDA Approved: NEXIUM 24HR CLEARMINIS — Supplemental Application (Haleon US Holdings LLC)

  FDA approved a supplemental application for NEXIUM 24HR CLEARMINIS (esomeprazole magnesium) filed by Haleon US Holdings LLC.

• FDA approval · 2019-02-07
  FDA Approved: RABEPRAZOLE SODIUM — Supplemental Application (Lannett Company, Inc.)

  The FDA approved a supplemental application for Lannett Company's generic rabeprazole sodium product.

• FDA approval · 2019-01-31
  FDA Approved: RANITIDINE — Original Application (Rising Pharma Holdings, Inc.)

  The FDA approved an original ANDA for ranitidine from Rising Pharma Holdings, Inc., enabling the marketing of a generic ranitidine product.

• FDA approval · 2018-11-27
  FDA Approved: LANSOPRAZOLE — Original Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved the original Abbreviated New Drug Application for lansoprazole from Zydus Pharmaceuticals USA Inc., enabling a generic version …

• FDA approval · 2018-06-07
  FDA Approved: PROTONIX DELAYED-RELEASE — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)

  The FDA approved a supplemental application for PROTONIX DELAYED-RELEASE (pantoprazole sodium) submitted by Wyeth Pharmaceuticals LLC (Pfize…

• FDA approval · 2018-06-07
  FDA Approved: OMEPRAZOLE — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for omeprazole from Sandoz Inc, enabling the continued marketing of the generic omeprazole produ…