Gastroesophageal Reflux Disease
📧 Sign up to get email alerts when something new happens for Gastroesophageal Reflux Disease.
Sign up freeTop drugs studied for this disease
-
FDA approval · 2013-12-07FDA Approved: PEPCID COMPLETE — Supplemental Application (Lil' Drug Store Products, Inc.)
FDA approved a supplemental application for Pepcid Complete, a chewable tablet that combines famotidine with calcium carbonate and magnesium…
-
FDA approval · 2013-11-15FDA Approved: ZEGERID OTC — Supplemental Application (Riley Consumer Care LLC)
The FDA approved a supplemental application for ZEGERID OTC (omeprazole and sodium bicarbonate) submitted by Riley Consumer Care LLC.
-
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…
-
FDA approval · 2013-11-08FDA 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 · 2013-10-31FDA 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 …
- Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
-
FDA approval · 2013-10-04FDA Approved: NEXIUM — Supplemental Application (AstraZeneca Pharmaceuticals LP)
FDA approved a supplemental application for Nexium (esomeprazole magnesium) submitted by AstraZeneca Pharmaceuticals LP.
-
FDA approval · 2013-09-06FDA Approved: PRILOSEC OTC — Supplemental Application (The Procter & Gamble Manufacturing Company)
FDA approves a supplemental application expanding Prilosec OTC (omeprazole magnesium) to over-the-counter use.
-
FDA approval · 2013-08-27FDA 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 · 2013-08-20FDA Approved: DEXILANT — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for Dexilant (dexlansoprazole) submitted by Takeda Pharmaceuticals America, Inc., resulting in updat…
-
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…
-
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…
-
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…
-
FDA approval · 2013-06-30FDA 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 · 2013-06-13FDA 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…
-
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…
-
FDA approval · 2013-05-17FDA Approved: PANTOPRAZOLE — Supplemental Application (NorthStar RxLLC)
FDA approved a supplemental application for Pantoprazole (ANDA077619) filed by NorthStar RxLLC.
-
FDA approval · 2013-05-15FDA Approved: PRILOSEC — Supplemental Application (Covis Pharma US, Inc)
The FDA approved a supplemental application for Prilosec (omeprazole magnesium) filed by Covis Pharma US, Inc.
-
FDA approval · 2013-04-19FDA 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 · 2013-04-19FDA 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…
-
FDA approval · 2013-04-19FDA Approved: METOCLOPRAMIDE — Original Application (Fresenius Kabi USA, LLC)
FDA approved Fresenius Kabi USA's original application for metoclopramide hydrochloride, a generic version of metoclopramide.
-
FDA approval · 2013-04-05FDA 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…
-
FDA approval · 2013-04-01FDA Approved: PEPCID AC MAXIMUM STRENGTH — Supplemental Application (Kenvue Brands LLC)
The FDA approved a supplemental application for Pepcid AC Maximum Strength (famotidine) by Kenvue Brands LLC.
-
FDA approval · 2013-02-22FDA Approved: FAMOTIDINE — Supplemental Application (Alembic Pharmaceuticals Inc.)
FDA approved a supplemental application for famotidine submitted by Alembic Pharmaceuticals Inc.
-
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…
-
FDA approval · 2012-12-19FDA Approved: FAMOTIDINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for famotidine from Teva Pharmaceuticals USA, Inc., signaling an approved modification to the produc…