Duodenal Ulcer

• FDA approval · 2008-11-24
  FDA Approved: ACID CONTROLLER — Supplemental Application (H E B)

  FDA approved a supplemental application for ACID CONTROLLER (famotidine) from H E B. The approval expands the product's labeling/indications…

• FDA approval · 2008-09-12
  FDA Approved: SUCRALFATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for sucralfate by Teva Pharmaceuticals USA, Inc., marking an approved modification to the generic pr…

• FDA approval · 2008-06-30
  FDA Approved: ACIPHEX — Supplemental Application (Waylis Therapeutics LLC)

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

• FDA approval · 2008-06-25
  FDA Approved: FAMOTIDINE — Original Application (Mylan Institutional LLC)

  The FDA approved a generic famotidine product from Mylan Institutional LLC under an original ANDA.

• FDA approval · 2008-06-03
  FDA Approved: FAMOTIDINE — Supplemental Application (Sagent Pharmaceuticals)

  The FDA approved Sagent Pharmaceuticals' supplemental application for famotidine under an existing ANDA, updating the product's approved lab…

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• FDA approval · 2008-06-03
  FDA Approved: FAMOTIDINE — Supplemental Application (Sagent Pharmaceuticals)

  FDA approved a supplemental application for famotidine from Sagent Pharmaceuticals, confirming the generic product under ANDA075651.

• FDA approval · 2008-05-20
  FDA Approved: FAMOTIDINE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for famotidine (Hikma Pharmaceuticals USA Inc.). The approval updates the labeling to reflect additi…

• FDA approval · 2008-04-21
  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 · 2008-04-21
  FDA Approved: PREVACID SOLUTAB — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approves a supplemental application for PREVACID SOLUTAB (lansoprazole) filed by Takeda Pharmaceuticals America, expanding the product's…

• FDA approval · 2008-02-27
  FDA Approved: NEXIUM — Original Application (AstraZeneca Pharmaceuticals LP)

  FDA approved Nexium (esomeprazole magnesium) through its Original Application, marking its original approval as a proton pump inhibitor for …

• FDA approval · 2008-02-27
  FDA Approved: FAMOTIDINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for famotidine from Teva Pharmaceuticals USA, Inc., updating the approved generic product.

• FDA approval · 2008-02-06
  FDA Approved: ACID REDUCER PLUS ANTACID — Original Application (CVS Pharmacy)

  FDA approved the original application for ACID REDUCER PLUS ANTACID, a combination product containing famotidine with calcium carbonate and …

• FDA approval · 2008-01-16
  FDA Approved: SUCRALFATE — Supplemental Application (Chartwell RX, LLC)

  The FDA approved a supplemental application for SUCRALFATE submitted by Chartwell RX, LLC.

• FDA approval · 2007-12-21
  FDA Approved: OMEPRAZOLE AND SODIUM BICARBONATE — Supplemental Application (Oceanside Pharmaceuticals)

  FDA approved a supplemental application for the combination product omeprazole and sodium bicarbonate from Oceanside Pharmaceuticals.

• FDA approval · 2007-12-20
  FDA Approved: PROTONIX I.V. — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)

  FDA approved a supplemental application to add an intravenous form of pantoprazole (PROTONIX I.V.), expanding the approved route of administ…

• FDA approval · 2007-11-14
  FDA Approved: PROTONIX DELAYED-RELEASE — Original Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)

  FDA approved the original application for Pantoprazole sodium delayed-release (Protonix Delayed-Release) by Wyeth/Pfizer for the treatment o…

• FDA approval · 2007-10-22
  FDA Approved: OMEPRAZOLE — Original Application (Apotex Corp)

  FDA approved Apotex Corp's original application for a generic omeprazole product, enabling a generic option for treating gastroesophageal re…

• FDA approval · 2007-10-22
  FDA Approved: OMEPRAZOLE — Original Application (Quallent Pharmaceuticals Health LLC)

  FDA approved the original (ANDA) application for omeprazole from Quallent Pharmaceuticals Health LLC, authorizing a generic omeprazole produ…

• FDA approval · 2007-09-21
  FDA Approved: RANITIDINE — Original Application (Pharmaceutical Associates, Inc.)

  FDA approved an original application for ranitidine (generic) by Pharmaceutical Associates, Inc.

• FDA approval · 2007-08-31
  FDA Approved: RANITIDINE — Original Application (Dr. Reddy's Laboratories Limited)

  FDA approved the original ANDA for ranitidine from Dr. Reddy's Laboratories Limited, enabling a generic ranitidine product to be marketed in…

• FDA approval · 2007-04-27
  FDA Approved: NEXIUM — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for Nexium (esomeprazole magnesium) from AstraZeneca, resulting in updated labeling.

• FDA approval · 2007-04-26
  FDA Approved: SUCRALFATE — Supplemental Application (Mylan Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for sucralfate from Mylan Pharmaceuticals, Inc., indicating an approved modification to the prod…

• FDA approval · 2007-04-26
  FDA Approved: CARAFATE — Supplemental Application (Allergan, Inc.)

  FDA approved a supplemental application for CARAFATE (sucralfate) from Allergan, Inc., resulting in updated labeling and/or indication infor…

• FDA approval · 2007-03-21
  FDA Approved: OMEPRAZOLE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for omeprazole by Sandoz Inc. This action updates the current approval for this generic drug.

• FDA approval · 2007-03-16
  FDA Approved: CIMETIDINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva's supplemental application for cimetidine, approving changes to its labeling/indication. This update broadens or clarifies…