Erosive Esophagitis

• FDA approval · 2015-02-25
  FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA has approved a supplemental application for Pantoprazole Sodium from Torrent Pharmaceuticals Limited, resulting in the approval of the g…

• 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 · 2015-01-02
  FDA Approved: OMEPRAZOLE — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  FDA approves a supplemental application for omeprazole from Quallent Pharmaceuticals Health LLC, authorizing an additional formulation/produ…

• FDA approval · 2014-12-21
  FDA Approved: PANTOPRAZOLE — Supplemental Application (NorthStar RxLLC)

  The FDA approved a supplemental application for pantoprazole submitted by NorthStar RxLLC under the ANDA pathway.

• FDA approval · 2014-12-19
  FDA Approved: PROTONIX I.V. — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)

  FDA approved a supplemental application to add the intravenous form of Protonix (pantoprazole sodium) to Wyeth/Pfizer's product line, expand…

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• FDA approval · 2014-12-19
  FDA Approved: NEXIUM — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approved a supplemental application for Nexium (esomeprazole magnesium) submitted by AstraZeneca Pharmaceuticals LP.

• FDA approval · 2014-12-19
  FDA Approved: PREVACID SOLUTAB — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

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

• 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, likely reflecting a labeling o…

• 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 · 2014-12-19
  FDA Approved: PREVACID — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

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

• FDA approval · 2014-12-19
  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 (Pfizer). …

• FDA approval · 2014-12-19
  FDA Approved: DEXILANT — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for Dexilant (dexlansoprazole) by Takeda Pharmaceuticals America, Inc.

• 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.

• FDA approval · 2014-12-10
  FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Lannett Company, Inc.)

  FDA approved a supplemental application for Pantoprazole Sodium from Lannett Company, Inc., confirming the generic version of this product.

• 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 · 2014-10-31
  FDA Approved: OMEPRAZOLE — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's generic omeprazole, establishing bioequivalence to the reference product and authorizing its marketing in the United…

• FDA approval · 2014-09-26
  FDA Approved: PROTONIX I.V. — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)

  FDA approves a supplemental application for PROTONIX I.V., authorizing the intravenous form of pantoprazole sodium.

• FDA approval · 2014-09-26
  FDA Approved: TAGAMET — Supplemental Application (Prestige Brands Holdings, Inc.)

  The FDA approved a supplemental application for Tagamet (cimetidine) filed by Prestige Brands Holdings, Inc., likely resulting in labeling c…

• FDA approval · 2014-09-10
  FDA Approved: PANTOPRAZOLE SODIUM — Original Application (XLCare Pharmaceuticals Inc.)

  FDA approves the original abbreviated new drug application for pantoprazole sodium, enabling a generic pantoprazole product from XLCare Phar…

• FDA approval · 2014-08-05
  FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Lannett Company, Inc.)

  FDA approved a supplemental application for pantoprazole sodium by Lannett Company, Inc. under an ANDA.

• 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 · 2014-02-25
  FDA Approved: PRILOSEC — Supplemental Application (Covis Pharma US, Inc)

  FDA approved a supplemental application for Prilosec (omeprazole magnesium) from Covis Pharma US, Inc. The approval updates the labeling for…