Gastroesophageal Reflux Disease

• 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 · 2009-09-16
  FDA Approved: METOCLOPRAMIDE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved ANI Pharmaceuticals' supplemental application for METOCLOPRAMIDE, authorizing the manufacture and marketing of a generic me…

• FDA approval · 2009-09-11
  FDA Approved: METOCLOPRAMIDE HYDROCHLORIDE — Supplemental Application (Chartwell Governmental & Specialty RX, LLC.)

  FDA approved a supplemental application for METOCLOPRAMIDE HYDROCHLORIDE submitted by Chartwell Governmental & Specialty RX, LLC.

• FDA approval · 2009-09-04
  FDA Approved: REGLAN — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved ANI Pharmaceuticals' supplemental application for REGLAN (metoclopramide hydrochloride), enabling changes under a supplemen…

• FDA approval · 2009-08-31
  FDA Approved: RANITIDINE — Supplemental Application (Dr. Reddy's Laboratories Limited)

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

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• 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 · 2009-06-30
  FDA Approved: METOCLOPRAMIDE HYDROCHLORIDE — Supplemental Application (Chartwell Governmental & Specialty RX, LLC.)

  FDA approved a supplemental application for metoclopramide hydrochloride (generic), filed by Chartwell Governmental & Specialty RX, LLC., as…

• FDA approval · 2009-06-30
  FDA Approved: REGLAN — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Reglan (metoclopramide hydrochloride) submitted by ANI Pharmaceuticals, Inc. for NDA 017854.

• FDA approval · 2009-06-30
  FDA Approved: METOCLOPRAMIDE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved ANI Pharmaceuticals' supplemental application for metoclopramide.

• 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 · 2009-04-02
  FDA Approved: GOOD NEIGHBOR PHARMACY OMEPRAZOLE — Supplemental Application (Amerisource Bergen)

  FDA approved a supplemental application for Good Neighbor Pharmacy Omeprazole (omeprazole), enabling continued marketing of the product unde…

• 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 · 2009-01-30
  FDA Approved: DEXILANT — Original Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved Dexilant (dexlansoprazole) under an original application for the treatment of gastroesophageal reflux disease, including healin…

• 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.

• FDA approval · 2008-12-01
  FDA Approved: PRILOSEC — Supplemental Application (Covis Pharma US, Inc)

  FDA approved a supplemental application for Prilosec (omeprazole magnesium) by Covis Pharma US, Inc. to update and/or expand the product lab…

• 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 · 2008-10-28
  FDA Approved: METOCLOPRAMIDE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for metoclopramide from ANI Pharmaceuticals, Inc., for an already approved generic product. This…

• 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 · 2008-06-18
  FDA Approved: PRILOSEC OTC — Supplemental Application (The Procter & Gamble Manufacturing Company)

  FDA approved a supplemental application for PRILOSEC OTC (omeprazole magnesium) from The Procter & Gamble Manufacturing Company.

• FDA approval · 2008-06-12
  FDA Approved: METOCLOPRAMIDE — Original Application (Ipca Laboratories Limited)

  FDA approved the original generic application for metoclopramide by Ipca Laboratories Limited.

• 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…

• 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.