Duodenal Ulcer

• 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.

• FDA approval · 2019-02-07
  FDA Approved: RABEPRAZOLE SODIUM — Supplemental Application (Lannett Company, Inc.)

  The FDA approved a supplemental application for Lannett Company's generic rabeprazole sodium product.

• FDA approval · 2019-02-01
  FDA Approved: RABEPRAZOLE SODIUM — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for rabeprazole sodium (generic) submitted by Aurobindo Pharma Limited. This confirms an approve…

• FDA approval · 2019-01-31
  FDA Approved: RANITIDINE — Original Application (Rising Pharma Holdings, Inc.)

  The FDA approved an original ANDA for ranitidine from Rising Pharma Holdings, Inc., enabling the marketing of a generic ranitidine product.

• FDA approval · 2019-01-18
  FDA Approved: LANSOPRAZOLE — Original Application (Medcore LLC)

  The FDA approved Lansoprazole as an original generic application (ANDA) from Medcore LLC, making a generic version available.

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• FDA approval · 2018-11-30
  FDA Approved: RABEPRAZOLE SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for Rabeprazole SODIUM from Torrent Pharmaceuticals Limited.

• FDA approval · 2018-11-27
  FDA Approved: LANSOPRAZOLE — Original Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved the original Abbreviated New Drug Application for lansoprazole from Zydus Pharmaceuticals USA Inc., enabling a generic version …

• FDA approval · 2018-11-05
  FDA Approved: OMEPRAZOLE — Original Application (BluePoint Laboratories)

  FDA approved BluePoint Laboratories' original ANDA for a generic omeprazole product. Omeprazole is a proton pump inhibitor indicated for gas…

• FDA approval · 2018-10-05
  FDA Approved: BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE — Supplemental Application (H2-Pharma, LLC)

  FDA approved a supplemental application for the combination of bismuth subitrate potassium, metronidazole, and tetracycline hydrochloride (H…

• FDA approval · 2018-09-27
  FDA Approved: RANITIDINE — Original Application (Ajanta Pharma USA Inc.)

  FDA approved Ajanta Pharma USA Inc.'s Original Application for ranitidine, a generic H2 blocker, with label indications including treatment …

• 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: 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: 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: 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 (Aurobindo Pharma Limited)

  FDA approved a supplemental application for omeprazole from Aurobindo Pharma Limited, authorizing their generic omeprazole product.

• 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…