Erosive Esophagitis

• FDA approval · 2012-12-12
  FDA Approved: FAMOTIDINE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for famotidine filed by Chartwell RX, LLC.

• 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.

• FDA approval · 2012-11-09
  FDA Approved: OMEPRAZOLE AND SODIUM BICARBONATE — Supplemental Application (Oceanside Pharmaceuticals)

  FDA approved Oceanside Pharmaceuticals' supplemental application for the fixed-dose combination of omeprazole and sodium bicarbonate, with u…

• FDA approval · 2012-11-02
  FDA Approved: OMEPRAZOLE — Supplemental Application (Lannett Company, Inc.)

  FDA approved a supplemental application for omeprazole submitted by Lannett Company, Inc. The approval pertains to a change to the marketed …

• FDA approval · 2012-10-09
  FDA Approved: NEXIUM — Supplemental Application (AstraZeneca Pharmaceuticals LP)

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

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• FDA approval · 2012-10-09
  FDA Approved: PROTONIX DELAYED-RELEASE — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)

  FDA approved a supplemental application for Protonix Delayed-Release (pantoprazole sodium) from Wyeth/Pfizer to modify/expand its labeling.

• FDA approval · 2012-10-09
  FDA Approved: PRILOSEC — Supplemental Application (Covis Pharma US, Inc)

  FDA approved a supplemental application for Prilosec (omeprazole magnesium) by Covis Pharma US, Inc, indicating an approved update to the la…

• FDA approval · 2012-10-05
  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 · 2012-09-28
  FDA Approved: DEXILANT — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for Dexilant (lansoprazole) from Takeda Pharmaceuticals America, expanding its labeling and indicati…

• FDA approval · 2012-09-28
  FDA Approved: NEXIUM — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for Nexium (esomeprazole magnesium) from AstraZeneca Pharmaceuticals LP.

• FDA approval · 2012-09-28
  FDA Approved: NEXIUM — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for Nexium (esomeprazole magnesium) from AstraZeneca Pharmaceuticals LP.

• FDA approval · 2012-09-28
  FDA Approved: PREVACID SOLUTAB — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

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

• FDA approval · 2012-09-28
  FDA Approved: PROTONIX I.V. — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)

  The FDA approved a supplemental application to add an intravenous formulation of pantoprazole (PROTONIX I.V.) from Wyeth Pharmaceuticals (Pf…

• FDA approval · 2012-09-28
  FDA Approved: PANTOPRAZOLE SODIUM — Original Application (NorthStar Rx LLC)

  FDA approves Pantoprazole sodium from NorthStar Rx LLC as an Original Application (ANDA), making a generic proton pump inhibitor available f…

• FDA approval · 2012-09-10
  FDA Approved: GOOD NEIGHBOR PHARMACY OMEPRAZOLE — Supplemental Application (Amerisource Bergen)

  FDA approved a supplemental application for GOOD NEIGHBOR PHARMACY OMEPRAZOLE (omeprazole) under NDA 022032, with Amerisource Bergen as the …

• FDA approval · 2012-09-07
  FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for Pantoprazole sodium from Mylan Pharmaceuticals Inc., continuing approval for this generic produc…

• FDA approval · 2012-08-27
  FDA Approved: OMEPRAZOLE MAGNESIUM — Supplemental Application (Gericare Pharmaceuticals)

  FDA approved a supplemental application for Omeprazole Magnesium by Gericare Pharmaceuticals under ANDA078878, approving the changes describ…

• FDA approval · 2012-06-13
  FDA Approved: FAMOTIDINE — Supplemental Application (Carlsbad Technology, Inc)

  FDA approved a supplemental application for famotidine from Carlsbad Technology, Inc.

• FDA approval · 2012-05-18
  FDA Approved: BASIC CARE LANSOPRAZOLE — Original Application (Amazon.com Services LLC)

  FDA approved a generic lansoprazole product, BASIC CARE LANSOPRAZOLE, under an original application by Amazon.com Services LLC. This provide…

• FDA approval · 2012-05-18
  FDA Approved: LANSOPRAZOLE — Original Application (Dr. Reddy's Laboratories Inc.)

  FDA approved the original ANDA for lansoprazole from Dr. Reddy's Laboratories, authorizing a generic lansoprazole product.

• FDA approval · 2012-05-11
  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 (Pfizer).

• FDA approval · 2012-05-10
  FDA Approved: PROTONIX I.V. — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)

  The FDA approved a supplemental application for PROTONIX I.V. (pantoprazole sodium) from Wyeth Pharmaceuticals (Pfizer).

• FDA approval · 2012-05-08
  FDA Approved: ACIPHEX — Supplemental Application (Waylis Therapeutics LLC)

  The FDA approved Waylis Therapeutics LLC's supplemental application for ACIPHEX (rabeprazole sodium).

• FDA approval · 2012-04-19
  FDA Approved: OMEPRAZOLE AND SODIUM BICARBONATE — Supplemental Application (Oceanside Pharmaceuticals)

  The FDA approved Oceanside Pharmaceuticals' supplemental application for an omeprazole and sodium bicarbonate product, updating its labeling…

• FDA approval · 2012-04-18
  FDA Approved: LANSOPRAZOLE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva Pharmaceuticals USA, Inc.'s supplemental application for lansoprazole, authorizing the marketing of a generic lansoprazole…