Gastroesophageal Reflux Disease

• 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.

• 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 · 2020-09-15
  FDA Approved: FAMOTIDINE — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for famotidine from Mylan Institutional LLC.

• 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…

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• FDA approval · 2020-09-09
  FDA Approved: FAMOTIDINE — Supplemental Application (Sagent Pharmaceuticals)

  FDA supplemental application submission for famotidine by Sagent Pharmaceuticals.

• FDA approval · 2020-08-20
  FDA Approved: LANSOPRAZOLE — Supplemental Application (Xiromed LLC)

  FDA approved a supplemental application for lansoprazole by Xiromed LLC, indicating an approved update to an already-approved product (such …

• FDA approval · 2020-06-30
  FDA Approved: PANTOPRAZOLE SODIUM — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Pantoprazole sodium as a generic pantoprazole product under an original application by Sun Pharmaceutical Industries, Inc.

• 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 · 2020-06-02
  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 · 2020-05-18
  FDA Approved: LANSOPRAZOLE — Original Application (Camber Pharmaceuticals, Inc.)

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

• FDA approval · 2020-05-14
  FDA Approved: ESOMEPRAZOLE MAGNESIUM — Original Application (Dr. Reddys Laboratories Inc)

  FDA approved an original-application generic esomeprazole magnesium from Dr. Reddy's Laboratories Inc.

• 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 · 2020-04-30
  FDA Approved: OMEPRAZOLE, SODIUM BICARBONATE — Original Application (Guardian Drug Company)

  FDA approved Guardian Drug Company's original application for omeprazole sodium bicarbonate, a generic proton pump inhibitor combination, fo…

• 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 · 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 · 2020-01-30
  FDA Approved: PRILOSEC OTC — Supplemental Application (The Procter & Gamble Manufacturing Company)

  The FDA approved a supplemental application for Prilosec OTC (omeprazole magnesium) submitted by The Procter & Gamble Manufacturing Company.

• 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).