Duodenal Ulcer

• FDA approval · 2020-11-27
  FDA Approved: OMEPRAZOLE — Supplemental Application (Apotex Corp)

  FDA approved Apotex Corp's supplemental application for omeprazole (generic), under ANDA076048.

• 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 (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: 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…

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• 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).

• 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.

• 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…

• 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 · 2020-04-30
  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.