Asthma

• FDA approval · 2011-08-18
  FDA Approved: DULERA — Supplemental Application (Organon LLC)

  The FDA approved a supplemental application for DULERA (mometasone furoate/formoterol fumarate dihydrate) submitted by Organon LLC.

• FDA approval · 2011-08-18
  FDA Approved: BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approved a supplemental application for Budesonide and Formoterol Fumarate Dihydrate (Symbicort) from AstraZeneca.

• FDA approval · 2011-08-08
  FDA Approved: ZAFIRLUKAST — Supplemental Application (Strides Pharma Science Limited)

  FDA approved a supplemental application for Zafirlukast submitted by Strides Pharma Science Limited.

• FDA approval · 2011-06-27
  FDA Approved: ADVAIR HFA — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for Advair HFA (fluticasone propionate and salmeterol xinafoate) submitted by GlaxoSmithKline LLC.

• FDA approval · 2011-06-27
  FDA Approved: ADVAIR DISKUS — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for Advair Diskus (fluticasone propionate and salmeterol) submitted by GlaxoSmithKline LLC.

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• FDA approval · 2011-06-27
  FDA Approved: SEREVENT DISKUS — Supplemental Application (GlaxoSmithKline LLC)

  The FDA approved a supplemental application for SEREVENT DISKUS (salmeterol xinafoate) filed by GlaxoSmithKline LLC. This action updates the…

• FDA approval · 2011-06-23
  FDA Approved: BUDESONIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for budesonide from Teva Pharmaceuticals USA, Inc.

• FDA approval · 2011-06-10
  FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)

  FDA approved Organon LLC's supplemental application for Singulair (montelukast sodium), granting approval of the requested supplemental acti…

• FDA approval · 2011-05-10
  FDA Approved: ADVAIR HFA — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for ADVAIR HFA (fluticasone propionate and salmeterol xinafoate) submitted by GlaxoSmithKline LLC.

• FDA approval · 2011-05-10
  FDA Approved: ADVAIR DISKUS — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental NDA for Advair Diskus (fluticasone propionate and salmeterol) submitted by GlaxoSmithKline LLC. The approval ind…

• FDA approval · 2011-04-27
  FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for Singulair (montelukast sodium) from Organon LLC.

• FDA approval · 2011-04-27
  FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)

  The FDA approved a supplemental application for Singulair (montelukast sodium) from Organon LLC.

• FDA approval · 2011-04-27
  FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for Singulair (montelukast sodium) submitted by Organon LLC, resulting in updated labeling for the p…

• FDA approval · 2011-04-13
  FDA Approved: THEOPHYLLINE — Original Application (Chartwell RX, LLC)

  FDA approved Chartwell RX, LLC's original application for Theophylline as a generic drug. The approval indicates authorization for a generic…

• FDA approval · 2011-04-08
  FDA Approved: TERBUTALINE SULFATE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved a supplemental application for Terbutaline Sulfate from Amneal Pharmaceuticals of New York LLC, authorizing a modification to a…

• FDA approval · 2011-04-08
  FDA Approved: TERBUTALINE SULFATE — Supplemental Application (Chartwell RX, LLC.)

  FDA approved a supplemental application for Terbutaline Sulfate filed by Chartwell RX, LLC., indicating approval of this generic product und…

• FDA approval · 2011-02-16
  FDA Approved: BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approved a supplemental application for budesonide and formoterol fumarate dihydrate (Symbicort) from AstraZeneca Pharmaceuticals LP.

• FDA approval · 2011-02-01
  FDA Approved: FORMOTEROL FUMARATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Formoterol Fumarate submitted by Mylan Pharmaceuticals, resulting in a change to the product…

• FDA approval · 2011-01-04
  FDA Approved: ADVAIR HFA — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for ADVAIR HFA submitted by GlaxoSmithKline LLC.

• FDA approval · 2011-01-04
  FDA Approved: ADVAIR DISKUS — Supplemental Application (GlaxoSmithKline LLC)

  The FDA approved a supplemental application for Advair Diskus submitted by GlaxoSmithKline LLC.

• FDA approval · 2010-12-30
  FDA Approved: SEREVENT DISKUS — Supplemental Application (GlaxoSmithKline LLC)

  The FDA approved a supplemental application for SEREVENT DISKUS (salmeterol xinafoate) submitted by GlaxoSmithKline LLC.

• FDA approval · 2010-12-21
  FDA Approved: XOLAIR — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for XOLAIR (omalizumab) submitted by Genentech, Inc., resulting in updated labeling.

• FDA approval · 2010-12-10
  FDA Approved: ALBUTEROL SULFATE HFA — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva's supplemental application for Albuterol Sulfate HFA inhalation aerosol.

• FDA approval · 2010-12-08
  FDA Approved: ALBUTEROL SULFATE HFA — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for ALBUTEROL SULFATE HFA submitted by Teva Pharmaceuticals USA, Inc.

• FDA approval · 2010-11-18
  FDA Approved: SEREVENT DISKUS — Supplemental Application (GlaxoSmithKline LLC)

  The FDA approved a supplemental application for SEREVENT DISKUS (salmeterol xinafoate) submitted by GlaxoSmithKline LLC.