Erosive Esophagitis

• FDA approval · 2018-08-20
  FDA Approved: RANITIDINE — Original Application (Granules India Ltd)

  FDA approved Granules India Ltd's original application for ranitidine (generic). The product is intended for conditions such as duodenal and…

• FDA approval · 2018-07-23
  FDA Approved: ESOMEPRAZOLE MAGNESIUM — Supplemental Application (Sun Pharmaceutical Industries, Inc)

  FDA approved Sun Pharmaceutical Industries, Inc.'s supplemental application for Esomeprazole Magnesium. This approval authorizes the marketi…

• FDA approval · 2018-07-20
  FDA Approved: OMEPRAZOLE — Original Application (INNOVUS PHARMACEUTICALS, INC.)

  FDA approved a generic version of omeprazole (omeprazole and omeprazole magnesium) under ANDA210593 from Innovus Pharmaceuticals.

• FDA approval · 2018-06-12
  FDA Approved: BERKLEY AND JENSEN OMEPRAZOLE — Supplemental Application (BJWC)

  FDA approved a supplemental application for BERKLEY AND JENSEN OMEPRAZOLE (omeprazole) submitted by BJWC.

• FDA approval · 2018-06-07
  FDA Approved: PROTONIX DELAYED-RELEASE — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)

  The FDA approved a supplemental application for PROTONIX DELAYED-RELEASE (pantoprazole sodium) submitted by Wyeth Pharmaceuticals LLC (Pfize…

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• FDA approval · 2018-06-07
  FDA Approved: PREVACID — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for PREVACID (lansoprazole) filed by Takeda Pharmaceuticals America, Inc.

• FDA approval · 2018-06-07
  FDA Approved: OMEPRAZOLE — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  FDA approved a supplemental application for Omeprazole by Quallent Pharmaceuticals Health LLC.

• FDA approval · 2018-06-07
  FDA Approved: PROTONIX DELAYED-RELEASE — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)

  The FDA approved a supplemental application for PROTONIX DELAYED-RELEASE (pantoprazole sodium) submitted by Wyeth Pharmaceuticals LLC (Pfize…

• FDA approval · 2018-06-07
  FDA Approved: OMEPRAZOLE — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for omeprazole from Sandoz Inc, enabling the continued marketing of the generic omeprazole produ…

• FDA approval · 2018-06-07
  FDA Approved: DEXILANT — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for Dexilant (dexlansoprazole) submitted by Takeda Pharmaceuticals America, expanding its labeling t…

• FDA approval · 2018-06-07
  FDA Approved: ESOMEPRAZOLE STRONTIUM — Supplemental Application (R2 Pharma, LLC)

  The FDA approved a supplemental application for Esomeprazole Strontium submitted by R2 Pharma, LLC under NDA202342.

• FDA approval · 2018-06-07
  FDA Approved: OMEPRAZOLE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application (ANDA 203270) for Omeprazole from Aurobindo Pharma Limited, authorizing changes to an approved gener…

• FDA approval · 2018-06-07
  FDA Approved: OMEPRAZOLE — Supplemental Application (Golden State Medical Supply, Inc.)

  The FDA approved a supplemental application for the generic omeprazole from Golden State Medical Supply, Inc., authorizing changes to the ap…

• FDA approval · 2018-06-07
  FDA Approved: OMEPRAZOLE — Supplemental Application (Lannett Company, Inc.)

  The FDA approved a supplemental application for the generic Omeprazole from Lannett Company, Inc., granting continued approval for this prod…

• FDA approval · 2018-05-31
  FDA Approved: OMEPRAZOLE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  The FDA approved Glenmark's supplemental application for omeprazole, granting approval for the generic proton pump inhibitor product. This a…

• FDA approval · 2018-05-31
  FDA Approved: OMEPRAZOLE — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application for omeprazole from Dr. Reddy's Laboratories Limited under the ANDA pathway.

• FDA approval · 2018-04-30
  FDA Approved: ESOMEPRAZOLE MAGNESIUM — Original Application (Sun Pharmaceutical Industries, Inc)

  The FDA approved Sun Pharmaceutical's original application for Esomeprazole Magnesium, a proton pump inhibitor. It is used to treat gastroes…

• FDA approval · 2018-04-24
  FDA Approved: RABEPRAZOLE SODIUM — Original Application (Ascend Laboratories, LLC)

  FDA approved Rabeprazole sodium from Ascend Laboratories, LLC as an Original Application (ANDA 208644), authorizing a generic proton pump in…

• FDA approval · 2018-04-13
  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., indicating a regu…

• FDA approval · 2018-01-24
  FDA Approved: NEXIUM 24HR CLEARMINIS — Supplemental Application (Haleon US Holdings LLC)

  FDA approved a supplemental application for NEXIUM 24HR CLEARMINIS (esomeprazole magnesium) submitted by Haleon US Holdings LLC. The action …

• FDA approval · 2018-01-09
  FDA Approved: ACIPHEX — Supplemental Application (Waylis Therapeutics LLC)

  FDA approved a supplemental application for ACIPHEX (rabeprazole sodium) filed by Waylis Therapeutics LLC.

• FDA approval · 2017-12-20
  FDA Approved: PROTONIX I.V. — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)

  The FDA approved a supplemental application for PROTONIX I.V., approving its intravenous pantoprazole sodium formulation. This expands treat…

• FDA approval · 2017-11-30
  FDA Approved: EQUATE LANSOPRAZOLE — Supplemental Application (Wal-Mart Stores Inc)

  The FDA approved a supplemental application for Equate Lansoprazole, Wal-Mart's store-brand lansoprazole.

• FDA approval · 2017-11-15
  FDA Approved: EQUATE LANSOPRAZOLE — Supplemental Application (Wal-Mart Stores Inc)

  The FDA approved a supplemental application for Equate Lansoprazole (lansoprazole) filed by Wal-Mart Stores Inc. The action relates to this …

• FDA approval · 2017-10-30
  FDA Approved: GOOD NEIGHBOR PHARMACY OMEPRAZOLE — Supplemental Application (Amerisource Bergen)

  The FDA approved a supplemental application for Good Neighbor Pharmacy Omeprazole (omeprazole), with AmerisourceBergen as the manufacturer, …