Gastroesophageal Reflux Disease

• 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…

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• 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…

• FDA approval · 2012-04-16
  FDA Approved: LANSOPRAZOLE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for Lansoprazole from Teva Pharmaceuticals USA, Inc. The submission concerns a supplemental chan…

• FDA approval · 2012-03-23
  FDA Approved: OMEPRAZOLE — Supplemental Application (Apotex Corp)

  FDA approves Apotex Corp's supplemental application for omeprazole (generic) under ANDA076048. This authorizes the marketing of a generic om…

• FDA approval · 2012-03-14
  FDA Approved: METOCLOPRAMIDE HYDROCHLORIDE — Supplemental Application (Chartwell Governmental & Specialty RX, LLC.)

  The FDA approved a supplemental application for metoclopramide hydrochloride from Chartwell Governmental & Specialty RX, LLC., signaling an …

• FDA approval · 2012-03-08
  FDA Approved: METOCLOPRAMIDE — Supplemental Application (Ipca Laboratories Limited)

  FDA approved a supplemental application for metoclopramide from Ipca Laboratories Limited.

• FDA approval · 2012-02-29
  FDA Approved: ACID REDUCER — Original Application (WinCo Foods, LLC)

  FDA approved an original application for a generic ranitidine hydrochloride product called ACID REDUCER by WinCo Foods, LLC.

• FDA approval · 2012-02-16
  FDA Approved: OMEPRAZOLE — Supplemental Application (Lannett Company, Inc.)

  FDA approved a supplemental application for omeprazole from Lannett Company, Inc., authorizing a generic omeprazole product.

• FDA approval · 2012-02-14
  FDA Approved: OMEPRAZOLE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for omeprazole from Sandoz Inc, confirming an update to the approved generic product labeling. This …

• FDA approval · 2012-02-13
  FDA Approved: OMEPRAZOLE — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for omeprazole submitted by Sandoz Inc under ANDA075757 (generic omeprazole).

• FDA approval · 2012-02-09
  FDA Approved: OMEPRAZOLE — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  The FDA approved a supplemental application for a generic omeprazole product from Quallent Pharmaceuticals Health LLC under ANDA075576. This…

• FDA approval · 2012-01-31
  FDA Approved: LANSOPRAZOLE — Supplemental Application (Dr.Reddy's Laboratories Ltd.)

  FDA approved a supplemental application for Lansoprazole from Dr. Reddy's Laboratories Ltd.

• FDA approval · 2012-01-20
  FDA Approved: NEXIUM — Supplemental Application (AstraZeneca Pharmaceuticals LP)

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

• FDA approval · 2012-01-20
  FDA Approved: NEXIUM — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for Nexium (esomeprazole magnesium) from AstraZeneca, updating the labeling under a supplemental…

• FDA approval · 2012-01-17
  FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for Pantoprazole Sodium by Torrent Pharmaceuticals Limited. The approval denotes changes under a sup…

• FDA approval · 2012-01-17
  FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Lannett Company, Inc.)

  FDA approved a supplemental application for Pantoprazole Sodium by Lannett Company, Inc., authorizing the continued market approval of a gen…

• FDA approval · 2012-01-11
  FDA Approved: PANTOPRAZOLE — Supplemental Application (NorthStar RxLLC)

  FDA approved a supplemental application for pantoprazole submitted by NorthStar RxLLC.

• FDA approval · 2011-12-15
  FDA Approved: NEXIUM — Supplemental Application (AstraZeneca Pharmaceuticals LP)

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

• FDA approval · 2011-12-07
  FDA Approved: OMEPRAZOLE AND SODIUM BICARBONATE — Supplemental Application (Oceanside Pharmaceuticals)

  FDA approved a supplemental application for Oceanside Pharmaceuticals' omeprazole and sodium bicarbonate, updating labeling through a supple…

• FDA approval · 2011-12-07
  FDA Approved: PROTONIX I.V. — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)

  FDA approved a supplemental application to authorize the intravenous form of Protonix (pantoprazole sodium) from Wyeth Pharmaceuticals (Pfiz…

• FDA approval · 2011-10-31
  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).