Zollinger-ellison Syndrome
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Sign up freeTop drugs studied for this disease
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FDA approval · 2015-03-06FDA 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.
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FDA approval · 2015-03-02FDA Approved: OMEPRAZOLE — Supplemental Application (Zydus Lifesciences Limited)
FDA approved a supplemental application for omeprazole from Zydus Lifesciences Limited under the ANDA.
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FDA approval · 2015-02-25FDA 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…
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FDA approval · 2015-01-02FDA 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…
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FDA approval · 2014-12-12FDA Approved: OMEPRAZOLE — Supplemental Application (Apotex Corp)
The FDA approved Apotex Corp's supplemental application for a generic omeprazole product.
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FDA approval · 2014-12-10FDA 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.
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FDA approval · 2014-12-05FDA 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…
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FDA approval · 2014-11-05FDA 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…
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FDA approval · 2014-10-31FDA 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…
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FDA approval · 2014-09-26FDA 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…
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FDA approval · 2014-09-10FDA 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…
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FDA approval · 2014-08-05FDA 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 · 2014-05-30FDA 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…
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FDA approval · 2014-02-25FDA 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…
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FDA approval · 2013-12-10FDA 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…
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FDA approval · 2013-11-08FDA 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…
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FDA approval · 2013-08-16FDA 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…
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FDA approval · 2013-08-07FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for pantoprazole sodium from Mylan Pharmaceuticals Inc. under ANDA090970, allowing continued marketi…
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FDA approval · 2013-08-06FDA 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…
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FDA approval · 2013-06-13FDA 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…
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FDA approval · 2013-05-30FDA 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…
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FDA approval · 2013-05-17FDA Approved: PANTOPRAZOLE — Supplemental Application (NorthStar RxLLC)
FDA approved a supplemental application for Pantoprazole (ANDA077619) filed by NorthStar RxLLC.
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FDA approval · 2013-04-19FDA 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…
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FDA approval · 2013-02-22FDA Approved: FAMOTIDINE — Supplemental Application (Alembic Pharmaceuticals Inc.)
FDA approved a supplemental application for famotidine submitted by Alembic Pharmaceuticals Inc.
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FDA approval · 2013-02-11FDA Approved: NIZATIDINE — Supplemental Application (Epic Pharma, LLC)
FDA approved Epic Pharma, LLC's supplemental application to market a generic nizatidine product (an H2 receptor blocker) under an ANDA, expa…