Gastric Ulcer

• FDA approval · 2022-09-30
  FDA Approved: GOOD NEIGHBOR PHARMACY OMEPRAZOLE — Supplemental Application (Amerisource Bergen)

  FDA granted a supplemental approval for Good Neighbor Pharmacy Omeprazole (omeprazole) from AmerisourceBergen.

• FDA approval · 2022-09-14
  FDA Approved: RABEPRAZOLE SODIUM — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for Rabeprazole sodium submitted by Aurobindo Pharma Limited.

• FDA approval · 2022-09-14
  FDA Approved: RABEPRAZOLE SODIUM — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for rabeprazole sodium (Ascend Laboratories, LLC). This indicates regulatory approval of the generic…

• FDA approval · 2022-09-02
  FDA Approved: RABEPRAZOLE SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for rabeprazole sodium submitted by Torrent Pharmaceuticals Limited.

• FDA approval · 2022-08-29
  FDA Approved: PANTOPRAZOLE SODIUM — Original Application (Northstar Rx LLC)

  FDA approved Pantoprazole sodium as an original ANDA for a generic product manufactured by Northstar Rx LLC.

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• FDA approval · 2022-08-25
  FDA Approved: ZANTAC 360 — Supplemental Application (Chattem, Inc.)

  The FDA approved a supplemental application for ZANTAC 360 (famotidine) submitted by Chattem, Inc., under ANDA206531.

• FDA approval · 2022-08-11
  FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for pantoprazole sodium from Torrent Pharmaceuticals Limited. The action is a supplemental approval,…

• FDA approval · 2022-07-28
  FDA Approved: FAMOTIDINE — Supplemental Application (Akorn)

  FDA approved a supplemental application for famotidine from Akorn (ANDA 201995). This approval confirms continued availability of this gener…

• FDA approval · 2022-07-28
  FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Eugia US LLC)

  The FDA approved a supplemental application for pantoprazole sodium from Eugia US LLC. The action pertains to an already approved generic, t…

• FDA approval · 2022-07-28
  FDA Approved: CURIST ACID RELIEF — Supplemental Application (Little Pharma, Inc.)

  FDA granted a supplemental approval for Curist Acid Relief containing famotidine 20 mg from Little Pharma, Inc., updating the ANDA with the …

• FDA approval · 2022-07-26
  FDA Approved: PANTOPRAZOLE SODIUM DELAYED-RELEASE — Original Application (Lifestar Pharma LLC)

  FDA approved pantoprazole sodium delayed-release through an original application for Lifestar Pharma LLC.

• FDA approval · 2022-06-24
  FDA Approved: ESOMEPRAZOLE MAGNESIUM — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved the original ANDA for esomeprazole magnesium as a generic proton pump inhibitor manufactured by Rising Pharma Holdings, Inc.

• FDA approval · 2022-06-09
  FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Lannett Company, Inc.)

  FDA approved a supplemental application for pantoprazole sodium from Lannett Company, enabling the marketing of this generic proton pump inh…

• FDA approval · 2022-06-09
  FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (NorthStar Rx LLC)

  FDA approved a supplemental application for pantoprazole sodium from NorthStar Rx LLC, a generic pantoprazole product.

• FDA approval · 2022-06-03
  FDA Approved: FAMOTIDINE — Original Application (Zydus Lifesciences Limited)

  The FDA approved an original abbreviated new drug application (ANDA) for famotidine from Zydus Lifesciences Limited, making a generic versio…

• FDA approval · 2022-05-18
  FDA Approved: PANTOPRAZOLE SODIUM — Original Application (Novadoz Pharmaceuticals LLC)

  The FDA approved Pantoprazole sodium from Novadoz Pharmaceuticals LLC under an Original Application (ANDA216171), adding a generic pantopraz…

• FDA approval · 2022-05-18
  FDA Approved: PANTOPRAZOLE SODIUM — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approves Camber Pharmaceuticals' pantoprazole sodium as an original ANDA generic product. It is indicated for GERD-related conditions su…

• FDA approval · 2022-04-15
  FDA Approved: SUCRALFATE — Original Application (Amneal Pharmaceuticals NY LLC)

  The FDA approved Amneal Pharmaceuticals NY LLC's original ANDA for sucralfate, enabling a generic version to come to market. Sucralfate is a…

• FDA approval · 2022-04-14
  FDA Approved: LANSOPRAZOLE, AMOXICILLIN, CLARITHROMYCIN — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application to market a generic fixed-dose combination of lansoprazole, amoxicillin, and clarithromycin for Heli…

• FDA approval · 2022-03-04
  FDA Approved: ACIPHEX — Supplemental Application (Waylis Therapeutics LLC)

  The FDA approved a supplemental application for ACIPHEX (rabeprazole sodium) by Waylis Therapeutics LLC. The snippet does not specify the ex…

• FDA approval · 2022-03-04
  FDA Approved: PREVACID SOLUTAB — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approves a supplemental application for PREVACID SOLUTAB (lansoprazole) from Takeda Pharmaceuticals America, Inc.

• FDA approval · 2022-03-04
  FDA Approved: OMEPRAZOLE — Supplemental Application (Apotex Corp)

  FDA approved a supplemental application for Omeprazole submitted by Apotex Corp.

• FDA approval · 2022-03-04
  FDA Approved: OMEPRAZOLE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for omeprazole submitted by Zydus Lifesciences Limited. The exact scope of the supplement (such as l…

• FDA approval · 2022-03-04
  FDA Approved: OMEPRAZOLE — Supplemental Application (Lannett Company, Inc.)

  The FDA approved a supplemental application for a generic omeprazole product from Lannett Company, Inc.

• FDA approval · 2022-03-04
  FDA Approved: OMEPRAZOLE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  The FDA approved Glenmark's supplemental application for omeprazole, a generic proton pump inhibitor, expanding or updating its approval for…