Duodenal Ulcer

• 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 · 2015-05-06
  FDA Approved: PEPCID AC MAXIMUM STRENGTH — Supplemental Application (Kenvue Brands LLC)

  FDA approved a supplemental application for Pepcid AC Maximum Strength (famotidine) submitted by Kenvue Brands LLC. This action expands 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…

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• 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.

• FDA approval · 2015-02-25
  FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA has approved a supplemental application for Pantoprazole Sodium from Torrent Pharmaceuticals Limited, resulting in the approval of the g…

• FDA approval · 2015-01-02
  FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (NorthStar Rx LLC)

  The FDA approved a supplemental application for pantoprazole sodium filed by NorthStar Rx LLC.

• FDA approval · 2015-01-02
  FDA Approved: OMEPRAZOLE — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  FDA approves a supplemental application for omeprazole from Quallent Pharmaceuticals Health LLC, authorizing an additional formulation/produ…

• FDA approval · 2014-12-21
  FDA Approved: PANTOPRAZOLE — Supplemental Application (NorthStar RxLLC)

  The FDA approved a supplemental application for pantoprazole submitted by NorthStar RxLLC under the ANDA pathway.

• FDA approval · 2014-12-19
  FDA Approved: NEXIUM — Supplemental Application (AstraZeneca Pharmaceuticals LP)

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

• FDA approval · 2014-12-19
  FDA Approved: PREVACID SOLUTAB — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for PREVACID SOLUTAB (lansoprazole) by Takeda Pharmaceuticals America, Inc.

• FDA approval · 2014-12-19
  FDA Approved: ESOMEPRAZOLE STRONTIUM — Supplemental Application (R2 Pharma, LLC)

  FDA approved a supplemental application for esomeprazole strontium from R2 Pharma, LLC, granting approval of this salt form under NDA 202342…

• FDA approval · 2014-12-19
  FDA Approved: PREVACID — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

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

• FDA approval · 2014-12-19
  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) submitted by Wyeth Pharmaceuticals (Pfizer). …

• FDA approval · 2014-12-10
  FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Lannett Company, Inc.)

  FDA approved a supplemental application for Pantoprazole Sodium from Lannett Company, Inc., confirming the generic version of this product.

• FDA approval · 2014-12-05
  FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for pantoprazole sodium from Torrent Pharmaceuticals Limited, marking an update to the product's app…

• FDA approval · 2014-11-05
  FDA Approved: PROTONIX I.V. — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)

  The FDA approved a supplemental NDA for Protonix IV (pantoprazole sodium) from Wyeth Pharmaceuticals (Pfizer), confirming/adding the intrave…