Helicobacter Pylori Infection

• FDA approval · 2022-03-16
  FDA Approved: METRONIDAZOLE — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for METRONIDAZOLE submitted by Prasco Laboratories.

• 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: TALICIA — Supplemental Application (RedHill Biopharma Ltd)

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

• 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…

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• FDA approval · 2022-03-04
  FDA Approved: LANSOPRAZOLE, AMOXICILLIN, CLARITHROMYCIN — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for a generic triple-drug regimen of lansoprazole, amoxicillin, and clarithromycin (manufactured by …

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

  FDA approved a supplemental application for Camber Pharmaceuticals' Omeprazole, a generic proton pump inhibitor, under the ANDA process.

• FDA approval · 2022-02-28
  FDA Approved: OMEPRAZOLE — Supplemental Application (Apotex Corp)

  The FDA approved a supplemental application for omeprazole from Apotex Corp, supporting a new generic entry for the product.

• FDA approval · 2022-01-31
  FDA Approved: CLARITHROMYCIN — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approved Alembic Pharmaceuticals' generic clarithromycin under Original Application ANDA210459. This expands access to clarithromycin as…

• 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 · 2021-12-15
  FDA Approved: METRONIDAZOLE — Supplemental Application (Baxter Healthcare Corporation)

  The FDA approved a supplemental application for metronidazole from Baxter Healthcare Corporation.

• FDA approval · 2021-11-12
  FDA Approved: LANSOPRAZOLE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Camber Pharmaceuticals' lansoprazole, a generic proton pump inhibitor, under ANDA 203083.

• FDA approval · 2021-11-09
  FDA Approved: LANSOPRAZOLE — Supplemental Application (Ajanta Pharma USA Inc.)

  FDA approves Ajanta Pharma USA Inc.'s supplemental application for lansoprazole (generic). This action approves a generic Lansoprazole produ…

• FDA approval · 2021-10-15
  FDA Approved: LANSOPRAZOLE — Supplemental Application (Dr.Reddy's Laboratories Ltd.)

  The FDA approved a supplemental application for lansoprazole by Dr. Reddy's Laboratories Ltd. This approval updates the current marketing au…

• FDA approval · 2021-09-14
  FDA Approved: RABEPRAZOLE SODIUM — Supplemental Application (Ascend Laboratories, LLC)

  The FDA approved a supplemental application for rabeprazole sodium (generic) from Ascend Laboratories, LLC.

• FDA approval · 2021-08-30
  FDA Approved: RABEPRAZOLE SODIUM — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for a generic rabeprazole sodium product from Aurobindo Pharma Limited.

• FDA approval · 2021-07-07
  FDA Approved: BERKLEY AND JENSEN OMEPRAZOLE — Supplemental Application (BJWC)

  FDA approved a supplemental application for Berkley and Jensen Omeprazole (omeprazole). This approval supports updates to labeling and expan…

• 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 · 2020-12-10
  FDA Approved: OMEPRAZOLE — Original Application (Golden State Medical Supply, Inc.)

  FDA approved the original application for a generic omeprazole product (ANDA 212977) manufactured by Golden State Medical Supply, Inc.

• FDA approval · 2020-12-09
  FDA Approved: OMEPRAZOLE — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application for Omeprazole from Dr. Reddy's Laboratories Limited.

• 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: ESOMEPRAZOLE STRONTIUM — Supplemental Application (R2 Pharma, LLC)

  The FDA approved a supplemental application for esomeprazole strontium from R2 Pharma, LLC. This action authorizes the salt form of esomepra…

• 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: OMEPRAZOLE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for Omeprazole from Sandoz Inc (ANDA075757). The approval confirms the generic product under the app…

• FDA approval · 2020-11-27
  FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Civica, Inc.)

  FDA approved a supplemental application for Pantoprazole Sodium from Civica, Inc. (AP submission).