Peptic Ulcer Disease

• FDA approval · 2015-03-06
  FDA Approved: GOOD NEIGHBOR PHARMACY OMEPRAZOLE — Supplemental Application (Amerisource Bergen)

  FDA approved a supplemental application for Good Neighbor Pharmacy Omeprazole (omeprazole) submitted by AmerisourceBergen, under NDA 022032.

• FDA approval · 2015-01-02
  FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (NorthStar Rx LLC)

  The FDA approved a supplemental application for pantoprazole sodium filed by NorthStar Rx LLC.

• FDA approval · 2014-12-19
  FDA Approved: OMEPRAZOLE AND SODIUM BICARBONATE — Supplemental Application (Oceanside Pharmaceuticals)

  FDA approved a supplemental application for omeprazole and sodium bicarbonate from Oceanside Pharmaceuticals, indicating an approved change …

• FDA approval · 2014-12-19
  FDA Approved: ESOMEPRAZOLE STRONTIUM — Supplemental Application (R2 Pharma, LLC)

  FDA approved a supplemental application for esomeprazole strontium from R2 Pharma, LLC, granting approval of this salt form under NDA 202342…

• FDA approval · 2014-12-12
  FDA Approved: OMEPRAZOLE — Supplemental Application (Apotex Corp)

  The FDA approved Apotex Corp's supplemental application for a generic omeprazole product.

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• FDA approval · 2014-12-05
  FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for pantoprazole sodium from Torrent Pharmaceuticals Limited, marking an update to the product's app…

• FDA approval · 2014-11-05
  FDA Approved: PROTONIX I.V. — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)

  The FDA approved a supplemental NDA for Protonix IV (pantoprazole sodium) from Wyeth Pharmaceuticals (Pfizer), confirming/adding the intrave…

• FDA approval · 2014-10-31
  FDA Approved: OMEPRAZOLE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for omeprazole from Sandoz Inc, authorizing continued manufacture and sale of a generic omeprazole p…

• FDA approval · 2014-05-30
  FDA Approved: FAMOTIDINE — Original Application (Akorn)

  The FDA approved Akorn's original application for a generic famotidine product, enabling market entry of a competitor to the brand-name drug…

• FDA approval · 2014-05-28
  FDA Approved: BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE — Supplemental Application (H2-Pharma, LLC)

  FDA approved a supplemental application for the combination drug bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride,…

• FDA approval · 2014-02-05
  FDA Approved: BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE — Supplemental Application (H2-Pharma, LLC)

  FDA approved a supplemental application for Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride, a combination therap…

• FDA approval · 2014-01-07
  FDA Approved: CIMETIDINE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for the generic drug cimetidine by Mylan Pharmaceuticals Inc.

• FDA approval · 2013-12-19
  FDA Approved: OMEPRAZOLE — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for omeprazole from Sandoz Inc, authorizing updates to the approved generic product.

• FDA approval · 2013-10-31
  FDA Approved: OMEPRAZOLE MAGNESIUM — Supplemental Application (Gericare Pharmaceuticals)

  The FDA approved a supplemental application for omeprazole magnesium from Gericare Pharmaceuticals, granting approval for a generic product …

• FDA approval · 2013-08-14
  FDA Approved: BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE — Supplemental Application (H2-Pharma, LLC)

  FDA approved a supplemental NDA for a bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride product (NDA 050786) from …

• FDA approval · 2013-05-17
  FDA Approved: PANTOPRAZOLE — Supplemental Application (NorthStar RxLLC)

  FDA approved a supplemental application for Pantoprazole (ANDA077619) filed by NorthStar RxLLC.

• FDA approval · 2013-05-15
  FDA Approved: PRILOSEC — Supplemental Application (Covis Pharma US, Inc)

  The FDA approved a supplemental application for Prilosec (omeprazole magnesium) filed by Covis Pharma US, Inc.

• FDA approval · 2013-04-01
  FDA Approved: PEPCID AC MAXIMUM STRENGTH — Supplemental Application (Kenvue Brands LLC)

  The FDA approved a supplemental application for Pepcid AC Maximum Strength (famotidine) by Kenvue Brands LLC.

• FDA approval · 2013-03-04
  FDA Approved: SUCRALFATE — Supplemental Application (Mylan Pharmaceuticals, Inc.)

  FDA approved a supplemental application for SUCRALFATE submitted by Mylan Pharmaceuticals, Inc.

• FDA approval · 2013-03-04
  FDA Approved: CARAFATE — Supplemental Application (Allergan, Inc.)

  The FDA approved Allergan's supplemental application for Carafate (sucralfate). This action updates the labeling and approved uses based on …

• FDA approval · 2013-02-22
  FDA Approved: FAMOTIDINE — Supplemental Application (Alembic Pharmaceuticals Inc.)

  FDA approved a supplemental application for famotidine submitted by Alembic Pharmaceuticals Inc.

• FDA approval · 2013-02-11
  FDA Approved: NIZATIDINE — Supplemental Application (Epic Pharma, LLC)

  FDA approved Epic Pharma, LLC's supplemental application to market a generic nizatidine product (an H2 receptor blocker) under an ANDA, expa…

• FDA approval · 2013-01-23
  FDA Approved: BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE — Supplemental Application (H2-Pharma, LLC)

  FDA approved a supplemental application for the fixed-dose combination of bismuth subcitrate potassium, metronidazole, and tetracycline hydr…

• FDA approval · 2012-11-13
  FDA Approved: CIMETIDINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved Teva's supplemental application for cimetidine, resulting in an expanded label/approval for the drug.

• FDA approval · 2012-11-13
  FDA Approved: CIMETIDINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva Pharmaceuticals USA, Inc.'s supplemental application for cimetidine, updating the product under an existing approval.