Helicobacter Pylori Infection

• FDA approval · 2012-02-14
  FDA Approved: OMEPRAZOLE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for omeprazole from Sandoz Inc, confirming an update to the approved generic product labeling. This …

• FDA approval · 2012-02-09
  FDA Approved: OMEPRAZOLE — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  The FDA approved a supplemental application for a generic omeprazole product from Quallent Pharmaceuticals Health LLC under ANDA075576. This…

• FDA approval · 2012-01-31
  FDA Approved: LANSOPRAZOLE — Supplemental Application (Dr.Reddy's Laboratories Ltd.)

  FDA approved a supplemental application for Lansoprazole from Dr. Reddy's Laboratories Ltd.

• FDA approval · 2012-01-20
  FDA Approved: NEXIUM — Supplemental Application (AstraZeneca Pharmaceuticals LP)

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

• FDA approval · 2012-01-20
  FDA Approved: NEXIUM — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for Nexium (esomeprazole magnesium) from AstraZeneca, updating the labeling under a supplemental…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2011-06-01
  FDA Approved: PREVACID SOLUTAB — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for PREVACID SOLUTAB (lansoprazole) to add a Solutab formulation, submitted by Takeda Pharmaceut…

• FDA approval · 2011-01-19
  FDA Approved: BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE — Supplemental Application (H2-Pharma, LLC)

  FDA approved a supplemental application for Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride for the treatment of …

• FDA approval · 2011-01-19
  FDA Approved: PANTOPRAZOLE — Original Application (NorthStar RxLLC)

  FDA approved the original application for pantoprazole submitted by NorthStar RxLLC, launching a generic pantoprazole product.

• FDA approval · 2011-01-07
  FDA Approved: OMEPRAZOLE — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for omeprazole from Sandoz Inc., granting an additional approval under the ANDA for the generic …

• FDA approval · 2010-12-22
  FDA Approved: CLARITHROMYCIN — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for clarithromycin by Sandoz Inc., confirming the approval of a generic clarithromycin product under…

• FDA approval · 2010-09-03
  FDA Approved: PRILOSEC — Supplemental Application (Covis Pharma US, Inc)

  FDA approved a supplemental application for Prilosec (omeprazole magnesium) submitted by Covis Pharma US, Inc., representing a labeling amen…

• FDA approval · 2010-03-04
  FDA Approved: NEXIUM — Supplemental Application (AstraZeneca Pharmaceuticals LP)

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

• FDA approval · 2010-02-26
  FDA Approved: IDKIT HP ONE — Supplemental Application (Meridian Bioscience Israel Ltd)

  FDA Supplemental Application approval for IDKIT HP ONE, a 13C-urea citric acid breath test kit for detecting Helicobacter pylori infection.

• FDA approval · 2010-01-20
  FDA Approved: OMEPRAZOLE AND SODIUM BICARBONATE — Supplemental Application (Oceanside Pharmaceuticals)

  FDA approved a supplemental application to update the labeling for Omeprazole and Sodium Bicarbonate (Oceanside Pharmaceuticals).

• FDA approval · 2009-11-10
  FDA Approved: LANSOPRAZOLE — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved an original ANDA for lansoprazole from Teva Pharmaceuticals USA, Inc., allowing a generic version of the proton pump inhibitor.…

• FDA approval · 2009-06-18
  FDA Approved: NEXIUM — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for Nexium (esomeprazole magnesium) submitted by AstraZeneca Pharmaceuticals LP to update the la…

• FDA approval · 2009-03-04
  FDA Approved: CLARITHROMYCIN — Supplemental Application (Sandoz Inc)

  FDA approves a supplemental application for Clarithromycin from Sandoz Inc, granting approval to a generic version under an ANDA.

• FDA approval · 2009-02-02
  FDA Approved: AMOXICILLIN — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for amoxicillin from Teva Pharmaceuticals USA, Inc., resulting in updated labeling and specification…

• FDA approval · 2008-09-18
  FDA Approved: CLARITHROMYCIN — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for Clarithromycin from Sandoz Inc, marking regulatory clearance for changes to this generic ant…

• FDA approval · 2008-04-21
  FDA Approved: PREVACID — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

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

• FDA approval · 2008-04-21
  FDA Approved: PREVACID SOLUTAB — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approves a supplemental application for PREVACID SOLUTAB (lansoprazole) filed by Takeda Pharmaceuticals America, expanding the product's…

• FDA approval · 2007-10-22
  FDA Approved: OMEPRAZOLE — Original Application (Apotex Corp)

  FDA approved Apotex Corp's original application for a generic omeprazole product, enabling a generic option for treating gastroesophageal re…

• FDA approval · 2007-10-22
  FDA Approved: OMEPRAZOLE — Original Application (Quallent Pharmaceuticals Health LLC)

  FDA approved the original (ANDA) application for omeprazole from Quallent Pharmaceuticals Health LLC, authorizing a generic omeprazole produ…

• FDA approval · 2007-10-17
  FDA Approved: CLARITHROMYCIN — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for Clarithromycin submitted by Sandoz Inc, granting a supplemental approval for the product.

• FDA approval · 2007-08-20
  FDA Approved: CLARITHROMYCIN — Original Application (Chartwell RX, LLC.)

  FDA approved a generic version of clarithromycin from Chartwell RX, LLC through an Original Abbreviated New Drug Application (ANDA).