Chronic Obstructive Pulmonary Disease

• FDA approval · 2010-06-25
  FDA Approved: BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approved a supplemental application for budesonide/formoterol fumarate dihydrate, a combination inhaled corticosteroid and long-acting b…

• FDA approval · 2010-06-25
  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 · 2010-06-25
  FDA Approved: ADVAIR HFA — Supplemental Application (GlaxoSmithKline LLC)

  The FDA approved a supplemental application for Advair HFA (fluticasone propionate and salmeterol xinafoate) submitted by GlaxoSmithKline LL…

• FDA approval · 2010-05-03
  FDA Approved: FLUTICASONE PROPIONATE DISKUS — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for Fluticasone Propionate Diskus submitted by Prasco Laboratories.

• FDA approval · 2010-03-31
  FDA Approved: ALBUTEROL SULFATE — Supplemental Application (Nephron Pharmaceuticals Corporation)

  FDA approved a supplemental application for albuterol sulfate submitted by Nephron Pharmaceuticals Corporation.

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• FDA approval · 2009-12-17
  FDA Approved: SPIRIVA HANDIHALER — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Spiriva HandiHaler (tiotropium bromide) submitted by Boehringer Ingelheim Pharmaceuticals, u…

• FDA approval · 2009-09-15
  FDA Approved: ADVAIR HFA — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for Advair HFA (fluticasone propionate and salmeterol xinafoate) from GlaxoSmithKline. The action up…

• FDA approval · 2009-09-08
  FDA Approved: ALBUTEROL SULFATE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for albuterol sulfate by Sandoz Inc, updating an existing approved product.

• FDA approval · 2009-05-20
  FDA Approved: TERBUTALINE SULFATE — Original Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved Hikma Pharmaceuticals USA Inc.'s original ANDA for terbutaline sulfate, establishing a generic version of this bronchodilat…

• FDA approval · 2009-03-31
  FDA Approved: ADVAIR DISKUS — Supplemental Application (GlaxoSmithKline LLC)

  The FDA approved a supplemental application for ADVAIR DISKUS (fluticasone propionate and salmeterol) from GlaxoSmithKline LLC. The approval…

• FDA approval · 2009-03-20
  FDA Approved: LEVALBUTEROL — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approved Mylan's generic Levalbuterol for treatment or prevention of bronchospasm associated with reversible obstructive airway disease,…

• FDA approval · 2009-03-03
  FDA Approved: SPIRIVA HANDIHALER — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Spiriva HandiHaler (tiotropium bromide) from Boehringer Ingelheim Pharmaceuticals, Inc. The appr…

• FDA approval · 2009-03-03
  FDA Approved: IPRATROPIUM BROMIDE — Supplemental Application (NORTHSTAR RX LLC)

  FDA approved a supplemental application for a generic ipratropium bromide product from NorthStar RX LLC.

• FDA approval · 2009-02-27
  FDA Approved: BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for Budesonide and Formoterol Fumarate Dihydrate (Symbicort) by AstraZeneca Pharmaceuticals LP, …

• FDA approval · 2008-12-16
  FDA Approved: ALBUTEROL SULFATE — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approved Mylan Pharmaceuticals' original application for ALBUTEROL SULFATE as a generic product. Albuterol sulfate is a bronchodilator i…

• FDA approval · 2008-11-13
  FDA Approved: SPIRIVA HANDIHALER — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Spiriva HandiHaler (tiotropium bromide) submitted by Boehringer Ingelheim Pharmaceuticals, Inc.

• FDA approval · 2008-10-14
  FDA Approved: ATROVENT HFA — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  FDA approved a supplemental application for ATROVENT HFA (ipratropium bromide) filed by Boehringer Ingelheim Pharmaceuticals, Inc.

• FDA approval · 2008-09-16
  FDA Approved: IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE — Supplemental Application (Nephron Pharmaceuticals Corporation)

  The FDA approved a supplemental application for Nephron Pharmaceuticals Corporation's Ipratropium Bromide and Albuterol Sulfate product.

• FDA approval · 2008-09-16
  FDA Approved: ALBUTEROL SULFATE HFA — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for ALBUTEROL SULFATE HFA by Teva Pharmaceuticals USA, Inc., updating the product label through a su…

• FDA approval · 2008-08-27
  FDA Approved: VENTOLIN HFA — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for Ventolin HFA (albuterol sulfate) submitted by GlaxoSmithKline LLC. The approval covers the chang…

• FDA approval · 2008-07-31
  FDA Approved: ADVAIR HFA — Supplemental Application (GlaxoSmithKline LLC)

  The FDA approved a supplemental application for Advair HFA (fluticasone propionate and salmeterol xinafoate) submitted by GlaxoSmithKline LL…

• FDA approval · 2008-07-16
  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 · 2008-03-20
  FDA Approved: ADVAIR HFA — Supplemental Application (GlaxoSmithKline LLC)

  The FDA approved a supplemental application for Advair HFA (fluticasone propionate and salmeterol xinafoate) submitted by GlaxoSmithKline, u…

• FDA approval · 2008-03-20
  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 · 2008-02-05
  FDA Approved: XOPENEX HFA — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved a supplemental application for XOPENEX HFA (levalbuterol tartrate) from Lupin Pharmaceuticals, Inc.