Gastric Ulcer

• FDA approval · 2010-11-23
  FDA Approved: OMEPRAZOLE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for Omeprazole from Sandoz Inc, granting approval for this generic proton pump inhibitor under an AN…

• FDA approval · 2010-11-17
  FDA Approved: OMEPRAZOLE — Supplemental Application (Lannett Company, Inc.)

  The FDA approved a supplemental application for the generic omeprazole from Lannett Company, Inc., authorizing continued marketing under the…

• FDA approval · 2010-10-29
  FDA Approved: FAMOTIDINE — Supplemental Application (Dr.Reddy's Laboratories Limited)

  The FDA approved a supplemental application for famotidine from Dr. Reddy's Laboratories Limited, authorizing a modification to an existing …

• FDA approval · 2010-10-27
  FDA Approved: RANITIDINE — Supplemental Application (Pharmaceutical Associates, Inc.)

  The FDA approved a supplemental application for ranitidine submitted by Pharmaceutical Associates, Inc. The approval updates the product's e…

• FDA approval · 2010-09-03
  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) from Wyeth Pharmaceuticals LLC (a Pfizer subs…

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• FDA approval · 2010-09-03
  FDA Approved: ACIPHEX — Supplemental Application (Waylis Therapeutics LLC)

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

• FDA approval · 2010-09-03
  FDA Approved: OMEPRAZOLE AND SODIUM BICARBONATE — Supplemental Application (Oceanside Pharmaceuticals)

  The FDA approved Oceanside Pharmaceuticals' supplemental application for Omeprazole and Sodium Bicarbonate.

• FDA approval · 2010-09-03
  FDA Approved: PRILOSEC — Supplemental Application (Covis Pharma US, Inc)

  FDA approved a supplemental application for Prilosec (omeprazole magnesium) submitted by Covis Pharma US, Inc., representing a labeling amen…

• FDA approval · 2010-07-15
  FDA Approved: FAMOTIDINE — Supplemental Application (Alembic Pharmaceuticals Inc.)

  FDA approved a supplemental application for famotidine from Alembic Pharmaceuticals Inc., adding approved changes to the product under the A…

• FDA approval · 2010-07-15
  FDA Approved: FAMOTIDINE — Supplemental Application (Dr.Reddy's Laboratories Limited)

  FDA approved Dr. Reddy's Laboratories Limited's supplemental application for famotidine.

• FDA approval · 2010-06-29
  FDA Approved: FAMOTIDINE — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' original application for famotidine, a generic H2 blocker used for ulcers and GERD indications.

• FDA approval · 2010-05-27
  FDA Approved: FAMOTIDINE — Original Application (Navinta LLC)

  FDA approves Navinta LLC's original application for famotidine. This approval permits a generic version of famotidine to enter the market.

• FDA approval · 2010-04-30
  FDA Approved: RANITIDINE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  The FDA approved a supplemental application for ranitidine from Amneal Pharmaceuticals of New York LLC.

• FDA approval · 2010-03-04
  FDA Approved: NEXIUM — Supplemental Application (AstraZeneca Pharmaceuticals LP)

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

• FDA approval · 2010-01-20
  FDA Approved: OMEPRAZOLE AND SODIUM BICARBONATE — Supplemental Application (Oceanside Pharmaceuticals)

  FDA approved a supplemental application to update the labeling for Omeprazole and Sodium Bicarbonate (Oceanside Pharmaceuticals).

• FDA approval · 2009-11-18
  FDA Approved: NIZATIDINE — Original Application (Amneal Pharmaceuticals LLC)

  FDA approves Amneal's nizatidine original application (generic) for use in conditions treated by H2 blockers.

• FDA approval · 2009-11-10
  FDA Approved: LANSOPRAZOLE — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved an original ANDA for lansoprazole from Teva Pharmaceuticals USA, Inc., allowing a generic version of the proton pump inhibitor.…

• FDA approval · 2009-11-10
  FDA Approved: LANSOPRAZOLE — Original Application (Mylan Pharmaceuticals Inc.)

  The FDA approved Mylan Pharmaceuticals Inc.'s Original Application for a generic lansoprazole (Lansoprazole) under ANDA090763. Lansoprazole …

• FDA approval · 2009-09-21
  FDA Approved: GOOD NEIGHBOR PHARMACY OMEPRAZOLE — Supplemental Application (Amerisource Bergen)

  The FDA approved a supplemental application for Good Neighbor Pharmacy Omeprazole (omeprazole). This action typically updates labeling, manu…

• FDA approval · 2009-07-31
  FDA Approved: PREVACID SOLUTAB — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for PREVACID SOLUTAB (lansoprazole) to add the Solutab dosage form to the approved product line. The…

• FDA approval · 2009-06-18
  FDA Approved: NEXIUM — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for Nexium (esomeprazole magnesium) submitted by AstraZeneca Pharmaceuticals LP to update the la…

• FDA approval · 2009-04-06
  FDA Approved: RANITIDINE — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application for ranitidine submitted by Dr. Reddy's Laboratories Limited.

• FDA approval · 2009-02-27
  FDA Approved: CIMETIDINE 200 ACID REDUCER — Supplemental Application (Walgreen Company)

  FDA approved a supplemental application to approve Walgreens' Cimetidine 200 Acid Reducer as a generic cimetidine product.

• FDA approval · 2009-01-21
  FDA Approved: OMEPRAZOLE — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  The FDA approved a supplemental application for omeprazole filed by Quallent Pharmaceuticals Health LLC under an ANDA.

• FDA approval · 2009-01-21
  FDA Approved: OMEPRAZOLE — Original Application (Sandoz Inc)

  FDA approved the original application for omeprazole from Sandoz Inc, authorizing a generic version of this proton pump inhibitor.