Helicobacter Pylori Infection

• 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 (Camber Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Camber Pharmaceuticals' generic omeprazole.

• 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 · 2020-11-20
  FDA Approved: EQUATE LANSOPRAZOLE — Supplemental Application (Wal-Mart Stores Inc)

  FDA approved a supplemental application for EQUATE LANSOPRAZOLE (lansoprazole) from Wal-Mart Stores Inc.

• FDA approval · 2020-11-16
  FDA Approved: OMEPRAZOLE — Supplemental Application (OHM LABORATORIES INC.)

  FDA approved a supplemental application for Omeprazole from OHM Laboratories Inc., resulting in an updated approval for the generic product.

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• FDA approval · 2020-11-13
  FDA Approved: BERKLEY AND JENSEN OMEPRAZOLE — Supplemental Application (BJWC)

  FDA approved a supplemental application for Berkley and Jensen Omeprazole (omeprazole) under the BJWC label, allowing continued marketing wi…

• 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 · 2020-06-25
  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 · 2020-06-23
  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 · 2020-05-18
  FDA Approved: LANSOPRAZOLE — Original Application (Camber Pharmaceuticals, Inc.)

  The FDA approved Camber Pharmaceuticals' original application for a generic lansoprazole product.

• 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.

• 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 · 2020-03-25
  FDA Approved: OMEPRAZOLE — Original Application (CHAIN DRUG MARKETING ASSOCIATION, INC.)

  The FDA approves an original application for omeprazole (generic) submitted by Chain Drug Marketing Association, Inc., covering indications …

• 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 · 2019-11-29
  FDA Approved: RABEPRAZOLE SODIUM — Supplemental Application (Advagen Pharma Limited)

  FDA approved a supplemental application for Rabeprazole sodium by Advagen Pharma Limited.

• 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 · 2019-11-01
  FDA Approved: TALICIA — Original Application (RedHill Biopharma Ltd)

  FDA approved TALICIA, a fixed-dose combination of omeprazole magnesium, amoxicillin, and rifabutin, for Helicobacter pylori infection. The a…

• FDA approval · 2019-09-24
  FDA Approved: OMEPRAZOLE AND SODIUM BICARBONATE — Supplemental Application (Oceanside Pharmaceuticals)

  FDA approved a supplemental application for OMEPRAZOLE AND SODIUM BICARBONATE (omeprazole and sodium bicarbonate) from Oceanside Pharmaceuti…

• 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 · 2019-05-10
  FDA Approved: LANSOPRAZOLE — Supplemental Application (Dr.Reddy's Laboratories Ltd.)

  The FDA approved a supplemental application for Lansoprazole from Dr. Reddy's Laboratories Ltd., approving the generic product update.

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

  FDA approved a supplemental application for PROTONIX DELAYED-RELEASE (pantoprazole sodium) from Wyeth Pharmaceuticals (a Pfizer subsidiary).

• 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.