Peptic Ulcer Disease

• FDA approval · 2022-02-18
  FDA Approved: PEPCID AC MAXIMUM STRENGTH — Supplemental Application (Kenvue Brands LLC)

  The FDA approved a supplemental application for PEPCID AC MAXIMUM STRENGTH (famotidine) from Kenvue Brands LLC.

• FDA approval · 2022-01-07
  FDA Approved: FAMOTIDINE — Original Application (Ascend Laboratories, LLC)

  The FDA approved Ascend Laboratories' original application for famotidine, establishing a new generic entry for the acid-reducing medication…

• FDA approval · 2021-12-15
  FDA Approved: BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE — Supplemental Application (H2-Pharma, LLC)

  FDA approved a supplemental application for the combination therapy Bismuth subcitrate potassium, metronidazole and tetracycline hydrochlori…

• FDA approval · 2021-11-03
  FDA Approved: FAMOTIDINE — Original Application (Ascent Pharmaceuticals, Inc.)

  The FDA approves the original generic application for famotidine by Ascent Pharmaceuticals, Inc., enabling a generic version of this H2 bloc…

• FDA approval · 2021-10-21
  FDA Approved: GOOD NEIGHBOR PHARMACY OMEPRAZOLE — Supplemental Application (Amerisource Bergen)

  FDA approved a supplemental application for Good Neighbor Pharmacy Omeprazole (omeprazole) manufactured by AmerisourceBergen.

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• FDA approval · 2021-10-13
  FDA Approved: GLYCOPYRROLATE — Original Application (Nivagen Pharmaceuticals, Inc.)

  FDA approves an original ANDA for a generic glycopyrrolate product from Nivagen Pharmaceuticals.

• FDA approval · 2021-06-04
  FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for Pantoprazole Sodium (Sun Pharmaceutical Industries, Inc.), resulting in updated labeling for…

• FDA approval · 2021-02-19
  FDA Approved: FAMOTIDINE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for famotidine submitted by Chartwell RX, LLC (ANDA 075786). It authorizes changes to the approved g…

• FDA approval · 2021-02-05
  FDA Approved: LIBRAX — Supplemental Application (Bausch Health US, LLC)

  FDA approved a supplemental application for Librax (chlordiazepoxide hydrochloride and clidinium bromide) from Bausch Health US, LLC.

• FDA approval · 2021-02-01
  FDA Approved: LANSOPRAZOLE — Original Application (NorthStar Rx LLC)

  FDA approved NorthStar Rx LLC's Original Application for a generic lansoprazole. Lansoprazole is a proton pump inhibitor used to treat pepti…

• FDA approval · 2020-11-27
  FDA Approved: OMEPRAZOLE — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  The FDA approved a supplemental application for Omeprazole from Quallent Pharmaceuticals Health LLC (a generic proton pump inhibitor).

• FDA approval · 2020-11-27
  FDA Approved: OMEPRAZOLE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved a supplemental application for omeprazole from Glenmark Pharmaceuticals Inc., USA.

• FDA approval · 2020-11-27
  FDA Approved: OMEPRAZOLE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved the supplemental application for omeprazole submitted by Aurobindo Pharma Limited (ANDA 203270), granting approval for a generi…

• FDA approval · 2020-11-27
  FDA Approved: TALICIA — Supplemental Application (RedHill Biopharma Ltd)

  FDA approved a supplemental application for TALICIA (omeprazole magnesium, amoxicillin and rifabutin) from RedHill Biopharma Ltd.

• FDA approval · 2020-11-27
  FDA Approved: OMEPRAZOLE — Supplemental Application (Zydus Lifesciences Limited)

  The FDA approved a supplemental application for omeprazole from Zydus Lifesciences Limited, authorizing a generic omeprazole product. The ap…

• FDA approval · 2020-10-20
  FDA Approved: CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE — Original Application (Chartwell RX, LLC)

  FDA approves the fixed-dose combination of chlordiazepoxide hydrochloride and clidinium bromide under an original application for Chartwell …

• FDA approval · 2020-10-02
  FDA Approved: ESOMEPRAZOLE MAGNESIUM — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved Rising Pharma Holdings, Inc.'s esomeprazole magnesium as a generic product under an ANDA to treat acid-related disorders, inclu…

• FDA approval · 2020-09-11
  FDA Approved: PREVACID SOLUTAB — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for Prevacid Solutab (lansoprazole) from Takeda Pharmaceuticals America, Inc., related to the So…

• FDA approval · 2020-07-29
  FDA Approved: CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE — Original Application (Misemer Pharmaceuticals, Inc)

  FDA approved an original ANDA for chlordiazepoxide hydrochloride and clidinium bromide, a generic combination product used for GI spasms and…

• FDA approval · 2020-07-07
  FDA Approved: CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE — Original Application (Sunrise Pharmaceutical, Inc.)

  FDA approves Sunrise Pharmaceutical's original application for a generic fixed-dose combination of chlordiazepoxide hydrochloride and clidin…

• FDA approval · 2020-06-25
  FDA Approved: ACID REDUCER — Original Application (CVS Pharmacy)

  The FDA approved CVS Pharmacy's original application for a generic esomeprazole magnesium product (ACID REDUCER), expanding access to proton…

• 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 · 2020-03-03
  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 approval · 2020-02-21
  FDA Approved: CIMETIDINE 200 ACID REDUCER — Supplemental Application (Walgreen Company)

  The FDA approved a supplemental application for Walgreens' CIMETIDINE 200 ACID REDUCER, indicating approval of changes to the approved gener…

• FDA approval · 2020-01-03
  FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Lannett Company, Inc.)

  FDA approved a supplemental application for pantoprazole sodium from Lannett Company (ANDA 078281).