Gastric Ulcer

• FDA approval · 2014-10-31
  FDA Approved: OMEPRAZOLE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for omeprazole from Sandoz Inc, authorizing continued manufacture and sale of a generic omeprazole p…

• FDA approval · 2014-10-31
  FDA Approved: OMEPRAZOLE — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's generic omeprazole, establishing bioequivalence to the reference product and authorizing its marketing in the United…

• FDA approval · 2014-09-26
  FDA Approved: TAGAMET — Supplemental Application (Prestige Brands Holdings, Inc.)

  The FDA approved a supplemental application for Tagamet (cimetidine) filed by Prestige Brands Holdings, Inc., likely resulting in labeling c…

• FDA approval · 2014-09-10
  FDA Approved: PANTOPRAZOLE SODIUM — Original Application (XLCare Pharmaceuticals Inc.)

  FDA approves the original abbreviated new drug application for pantoprazole sodium, enabling a generic pantoprazole product from XLCare Phar…

• FDA approval · 2014-08-05
  FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Lannett Company, Inc.)

  FDA approved a supplemental application for pantoprazole sodium by Lannett Company, Inc. under an ANDA.

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• FDA approval · 2014-05-30
  FDA Approved: FAMOTIDINE — Original Application (Akorn)

  The FDA approved Akorn's original application for a generic famotidine product, enabling market entry of a competitor to the brand-name drug…

• FDA approval · 2014-05-28
  FDA Approved: BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE — Supplemental Application (H2-Pharma, LLC)

  FDA approved a supplemental application for the combination drug bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride,…

• FDA approval · 2014-02-25
  FDA Approved: PRILOSEC — Supplemental Application (Covis Pharma US, Inc)

  FDA approved a supplemental application for Prilosec (omeprazole magnesium) from Covis Pharma US, Inc. The approval updates the labeling for…

• FDA approval · 2014-02-14
  FDA Approved: OMEPRAZOLE MAGNESIUM — Supplemental Application (Gericare Pharmaceuticals)

  FDA approved a supplemental application for Omeprazole Magnesium by Gericare Pharmaceuticals, updating the approval status for this generic …

• FDA approval · 2014-01-07
  FDA Approved: CIMETIDINE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for the generic drug cimetidine by Mylan Pharmaceuticals Inc.

• FDA approval · 2013-12-20
  FDA Approved: OMEPRAZOLE AND SODIUM BICARBONATE — Supplemental Application (Oceanside Pharmaceuticals)

  The FDA approved a supplemental application for the combination product Omeprazole and Sodium Bicarbonate from Oceanside Pharmaceuticals.

• FDA approval · 2013-12-10
  FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Lannett Company, Inc.)

  FDA approved a supplemental application for pantoprazole sodium (generic) submitted by Lannett Company, Inc., indicating an additional regul…

• FDA approval · 2013-11-08
  FDA Approved: RABEPRAZOLE SODIUM — Original Application (Lannett Company, Inc.)

  FDA approved the original application for rabeprazole sodium from Lannett Company, Inc., enabling a generic version of the proton pump inhib…

• FDA approval · 2013-11-08
  FDA Approved: RABEPRAZOLE SODIUM — Original Application (Torrent Pharmaceuticals Limited)

  FDA approves Torrent Pharmaceuticals Limited's original application for generic rabeprazole sodium, a proton pump inhibitor indicated for ga…

• FDA approval · 2013-10-31
  FDA Approved: OMEPRAZOLE MAGNESIUM — Supplemental Application (Gericare Pharmaceuticals)

  The FDA approved a supplemental application for omeprazole magnesium from Gericare Pharmaceuticals, granting approval for a generic product …

• FDA approval · 2013-08-27
  FDA Approved: LANSOPRAZOLE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Lansoprazole from Mylan Pharmaceuticals Inc., resulting in approval of a generic Lansoprazol…

• FDA approval · 2013-08-16
  FDA Approved: GOOD NEIGHBOR PHARMACY OMEPRAZOLE — Supplemental Application (Amerisource Bergen)

  FDA approved a supplemental application for Good Neighbor Pharmacy's omeprazole, enabling changes to the previously approved labeling for th…

• FDA approval · 2013-08-14
  FDA Approved: BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE — Supplemental Application (H2-Pharma, LLC)

  FDA approved a supplemental NDA for a bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride product (NDA 050786) from …

• FDA approval · 2013-08-06
  FDA Approved: ESOMEPRAZOLE STRONTIUM — Original Application (R2 Pharma, LLC)

  FDA approved esomeprazole strontium via the Original Application (NDA202342) for indications consistent with proton pump inhibitors (GERD-re…

• FDA approval · 2013-06-30
  FDA Approved: OMEPRAZOLE — Supplemental Application (Apotex Corp)

  FDA approved a supplemental application for Omeprazole from Apotex Corp, confirming approval of a supplemental filing for this generic proto…

• FDA approval · 2013-06-13
  FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (NorthStar Rx LLC)

  The FDA approved a supplemental application for pantoprazole sodium from NorthStar Rx LLC, indicating an approved change to an existing pant…

• FDA approval · 2013-05-30
  FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for pantoprazole sodium submitted by Torrent Pharmaceuticals Limited (generic pantoprazole) under an…

• FDA approval · 2013-04-19
  FDA Approved: ACIPHEX — Supplemental Application (Waylis Therapeutics LLC)

  FDA approved a supplemental application for ACIPHEX (rabeprazole sodium) submitted by Waylis Therapeutics LLC. The action expands or updates…

• FDA approval · 2013-04-19
  FDA Approved: OMEPRAZOLE/SODIUM BICARBONATE — Original Application (Strides Pharma Science Limited)

  FDA approved Strides Pharma Science Limited's generic omeprazole/sodium bicarbonate (original application) for use as a proton pump inhibito…

• FDA approval · 2013-04-05
  FDA Approved: BASIC CARE LANSOPRAZOLE — Supplemental Application (Amazon.com Services LLC)

  FDA approved a supplemental application for BASIC CARE LANSOPRAZOLE (lansoprazole) from Amazon.com Services LLC, a generic lansoprazole prod…