Erosive Esophagitis

• FDA approval · 2016-02-25
  FDA Approved: OMEPRAZOLE — Supplemental Application (Lannett Company, Inc.)

  FDA approved a supplemental application for omeprazole from Lannett Company, Inc., effectively updating the product labeling under the ANDA.

• FDA approval · 2016-02-10
  FDA Approved: GOOD NEIGHBOR PHARMACY OMEPRAZOLE — Supplemental Application (Amerisource Bergen)

  FDA approved a supplemental application to authorize Good Neighbor Pharmacy Omeprazole (omeprazole) as a store-brand proton pump inhibitor m…

• FDA approval · 2016-02-03
  FDA Approved: PRILOSEC — Supplemental Application (Covis Pharma US, Inc)

  FDA approved a supplemental application for Prilosec (omeprazole magnesium) submitted by Covis Pharma US, Inc. The approval pertains to a mo…

• FDA approval · 2016-01-26
  FDA Approved: PANTOPRAZOLE SODIUM — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal Pharmaceuticals' original application for pantoprazole sodium, a generic pantoprazole product, expanding access to a pro…

• FDA approval · 2015-12-22
  FDA Approved: FAMOTIDINE — Original Application (Aurobindo Pharma Limited)

  FDA approved the original application for famotidine from Aurobindo Pharma Limited, enabling a generic version of famotidine to be marketed.

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• FDA approval · 2015-12-16
  FDA Approved: PREVACID SOLUTAB — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application to add PREVACID SOLUTAB (lansoprazole) as a soluble tablet formulation. This expands the approve…

• FDA approval · 2015-12-16
  FDA Approved: PREVACID — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for PREVACID (lansoprazole) submitted by Takeda Pharmaceuticals America, Inc. The approval updates t…

• FDA approval · 2015-11-09
  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/Pfizer, enabling IV…

• FDA approval · 2015-09-25
  FDA Approved: ESOMEPRAZOLE MAGNESIUM — Original Application (NorthStar Rx LLC)

  FDA approved the original application for esomeprazole magnesium from NorthStar Rx LLC, a generic version of the proton pump inhibitor esome…

• FDA approval · 2015-08-19
  FDA Approved: OMEPRAZOLE — Original Application (Aurobindo Pharma Limited)

  The FDA approved Aurobindo Pharma Limited's original application for a generic omeprazole product.

• FDA approval · 2015-08-03
  FDA Approved: ESOMEPRAZOLE MAGNESIUM — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approved an original application for Esomeprazole Magnesium from Mylan as a generic proton pump inhibitor. The approval makes a generic …

• FDA approval · 2015-07-31
  FDA Approved: RABEPRAZOLE SODIUM — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved the Original Application for a generic rabeprazole sodium product by Amneal Pharmaceuticals. The approval supporting use for ac…

• FDA approval · 2015-06-01
  FDA Approved: GOOD NEIGHBOR PHARMACY OMEPRAZOLE — Supplemental Application (Amerisource Bergen)

  The FDA approved a supplemental application for Good Neighbor Pharmacy Omeprazole (omeprazole) submitted by AmerisourceBergen, allowing the …

• FDA approval · 2015-04-20
  FDA Approved: PEPCID AC MAXIMUM STRENGTH — Supplemental Application (Kenvue Brands LLC)

  FDA approved a supplemental application for Pepcid AC Maximum Strength (famotidine) filed by Kenvue Brands LLC to update the OTC product lab…

• FDA approval · 2015-04-14
  FDA Approved: OMEPRAZOLE — Supplemental Application (Sandoz Inc)

  The FDA approved Sandoz Inc's supplemental application for omeprazole, a generic proton pump inhibitor.

• FDA approval · 2015-04-09
  FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for Pantoprazole Sodium from Torrent Pharmaceuticals Limited under the ANDA program. This action upd…

• FDA approval · 2015-04-08
  FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approves a supplemental application for pantoprazole sodium from Mylan Pharmaceuticals Inc. under ANDA.

• FDA approval · 2015-04-08
  FDA Approved: PANTOPRAZOLE — Supplemental Application (NorthStar RxLLC)

  FDA approves a supplemental application for pantoprazole from NorthStar RxLLC, indicating approval of a generic pantoprazole product.

• FDA approval · 2015-04-08
  FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (NorthStar Rx LLC)

  FDA approved a supplemental application for Pantoprazole Sodium from NorthStar Rx LLC under an ANDA (202038), authorizing regulatory action …

• FDA approval · 2015-04-03
  FDA Approved: RABEPRAZOLE SODIUM — Supplemental Application (Lannett Company, Inc.)

  FDA approved a supplemental application for Lannett's generic rabeprazole sodium (ANDA 090678), authorizing its marketing as a proton pump i…

• FDA approval · 2015-04-02
  FDA Approved: RABEPRAZOLE SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)

  The FDA approved a supplemental application for rabeprazole sodium from Torrent Pharmaceuticals Limited under ANDA 202376, indicating a post…

• FDA approval · 2015-03-20
  FDA Approved: OMEPRAZOLE — Supplemental Application (Apotex Corp)

  FDA approved a supplemental application for omeprazole from Apotex Corp., authorizing a generic version of the drug.

• FDA approval · 2015-03-16
  FDA Approved: OMEPRAZOLE — Supplemental Application (Dr. Reddy's Laboratories Limited)

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

• FDA approval · 2015-03-06
  FDA Approved: GOOD NEIGHBOR PHARMACY OMEPRAZOLE — Supplemental Application (Amerisource Bergen)

  FDA approved a supplemental application for Good Neighbor Pharmacy Omeprazole (omeprazole) submitted by AmerisourceBergen, under NDA 022032.

• FDA approval · 2015-03-02
  FDA Approved: OMEPRAZOLE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for omeprazole from Zydus Lifesciences Limited under the ANDA.