Gastric Ulcer
📧 Sign up to get email alerts when something new happens for Gastric Ulcer.
Sign up freeTop drugs studied for this disease
-
FDA approval · 2023-11-08FDA Approved: ESOMEPRAZOLE MAGNESIUM — Supplemental Application (Zydus Pharmaceuticals USA Inc.)
FDA approved a supplemental application for Esomeprazole Magnesium from Zydus Pharmaceuticals USA Inc., supporting its generic approval.
-
FDA approval · 2023-11-01FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Northstar Rx LLC)
The FDA approved a supplemental application for pantoprazole sodium from Northstar Rx LLC under an ANDA, authorizing updated manufacturing/l…
-
FDA approval · 2023-10-31FDA Approved: RABEPRAZOLE SODIUM — Supplemental Application (Ascend Laboratories, LLC)
FDA approved a supplemental application for Rabeprazole sodium submitted by Ascend Laboratories, LLC. This action approves the referenced ge…
-
FDA approval · 2023-10-27FDA Approved: PANTOPRAZOLE SODIUM — Original Application (Camber Pharmaceuticals, Inc.)
FDA approves Pantoprazole Sodium under an Original Application by Camber Pharmaceuticals, Inc.
-
FDA approval · 2023-10-11FDA Approved: NAPROXEN AND ESOMEPRAZOLE MAGNESIUM — Original Application (ScieGen Pharmaceuticals, Inc)
FDA approved Naproxen and Esomeprazole Magnesium (ScieGen Pharmaceuticals) under Original Application. The combination is indicated for reli…
- Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
-
FDA approval · 2023-10-11FDA Approved: OMEPRAZOLE — Supplemental Application (Sandoz Inc)
The FDA approved a supplemental application for Omeprazole from Sandoz Inc, granting regulatory approval for changes to the generic product'…
-
FDA approval · 2023-10-05FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Camber Pharmaceuticals, Inc.)
The FDA approved a supplemental application for Pantoprazole Sodium from Camber Pharmaceuticals, Inc. under ANDA213778.
-
FDA approval · 2023-09-29FDA Approved: ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES, 20 MG — Original Application (MARKSANS PHARMA LIMITED)
FDA approved Marksans Pharma Limited's esomeprazole magnesium delayed-release capsules, 20 mg, as a generic therapeutic option for common ac…
-
FDA approval · 2023-09-27FDA Approved: PANTOPRAZOLE — Supplemental Application (NorthStar RxLLC)
FDA approved a supplemental application for pantoprazole by NorthStar RxLLC under ANDA077619.
-
FDA approval · 2023-09-27FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Lannett Company, Inc.)
FDA approved a supplemental application for pantoprazole sodium by Lannett Company, Inc., approving changes to the product's labeling relate…
-
FDA approval · 2023-09-27FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)
The FDA approved a supplemental application for Pantoprazole Sodium from Torrent Pharmaceuticals Limited.
-
FDA approval · 2023-09-26FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (NorthStar Rx LLC)
FDA approved a supplemental application for Pantoprazole sodium from NorthStar Rx LLC.
-
FDA approval · 2023-09-18FDA Approved: PANTOPRAZOLE SODIUM DELAYED-RELEASE — Supplemental Application (Lifestar Pharma LLC)
FDA approved a supplemental application for Pantoprazole Sodium Delayed-Release from Lifestar Pharma LLC, approving a new generic pantoprazo…
-
FDA approval · 2023-09-18FDA Approved: FAMOTIDINE — Original Application (Ajanta Pharma USA Inc.)
FDA approved Ajanta Pharma USA Inc.'s original ANDA for famotidine, a generic version of the histamine-2 blocker.
-
FDA approval · 2023-09-14FDA Approved: FAMOTIDINE — Original Application (Micro Labs Limited)
FDA approved Micro Labs Limited's original ANDA for famotidine. This approval allows the marketing of a generic famotidine product.
-
FDA approval · 2023-09-11FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Novadoz Pharmaceuticals LLC)
The FDA approved a supplemental application for pantoprazole sodium filed by Novadoz Pharmaceuticals LLC. This action updates the product la…
-
CLINICAL_TRIALS trial_result · 2023-09-11Clinical Trial Update: MAGNET (Magnetically Controlled Capsule for Assessment of Gastric Mucosa in Symptomatic Patients) [NA]
Clinical trial MAGNET evaluating magnetically controlled capsule for gastric mucosa assessment has completed with results posted; conditions…
-
FDA approval · 2023-08-17FDA Approved: FAMOTIDINE — Original Application (Camber Pharmaceuticals, Inc.)
FDA approves Camber Pharmaceuticals' original application for famotidine, a generic H2 blocker used to treat ulcers and gastroesophageal ref…
-
FDA approval · 2023-08-16FDA Approved: LANSOPRAZOLE, AMOXICILLIN, CLARITHROMYCIN — Supplemental Application (Rising Pharma Holdings, Inc.)
FDA approved a supplemental application for a combination tablet containing lansoprazole, amoxicillin, and clarithromycin (Rising Pharma Hol…
-
FDA approval · 2023-08-08FDA Approved: PREVACID SOLUTAB — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for PREVACID SOLUTAB to include the lansoprazole Solutab formulation from Takeda Pharmaceuticals Ame…
-
FDA approval · 2023-08-02FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Eugia US LLC)
FDA approved a supplemental application for pantoprazole sodium from Eugia US LLC, adding a regulatory change to an existing pantoprazole pr…
-
FDA approval · 2023-07-18FDA 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). This act…
-
FDA approval · 2023-07-18FDA Approved: ACIPHEX — Supplemental Application (Waylis Therapeutics LLC)
FDA approved a supplemental application for ACIPHEX (rabeprazole sodium) submitted by Waylis Therapeutics LLC.
-
FDA approval · 2023-07-18FDA Approved: OMEPRAZOLE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)
FDA approved Glenmark's supplemental application for omeprazole (generic), granting changes to the approved ANDA product labeling.
-
FDA approval · 2023-07-18FDA Approved: LANSOPRAZOLE, AMOXICILLIN, CLARITHROMYCIN — Supplemental Application (Rising Pharma Holdings, Inc.)
The FDA granted supplemental approval for a lansoprazole-amoxicillin-clarithromycin combination product by Rising Pharma Holdings, Inc. to e…