Chronic Obstructive Pulmonary Disease

• FDA label_change · 2022-12-02
  FDA Approved: TRELEGY ELLIPTA — Supplemental Application (GlaxoSmithKline LLC)

  The FDA approved a supplemental application for TRELEGY ELLIPTA filed by GlaxoSmithKline, resulting in updated labeling. This represents a l…

• FDA label_change · 2019-06-06
  FDA Approved: INCRUSE ELLIPTA — Supplemental Application (GlaxoSmithKline LLC)

  The FDA lists a supplemental application decision for INCRUSE ELLIPTA (umeclidinium) from GlaxoSmithKline LLC, indicating a labeling change …

• FDA label_change · 2018-03-02
  FDA Approved: FLUTICASONE PROPIONATE AND SALMETEROL — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for the inhaled combination product fluticasone propionate and salmeterol, resulting in changes to i…

• FDA label_change · 2018-01-23
  FDA Approved: DALIRESP — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approved a supplemental application for DALIRESP (roflumilast) from AstraZeneca Pharmaceuticals LP, updating labeling.

• FDA label_change · 2016-11-09
  FDA Approved: ALBUTEROL SULFATE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for ALBUTEROL SULFATE from Sandoz Inc, resulting in changes to the product labeling.

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• FDA label_change · 2016-09-08
  FDA Approved: PROAIR DIGIHALER — Supplemental Application (Teva Respiratory, LLC)

  The FDA approved a supplemental application for ProAir Digihaler (albuterol sulfate) by Teva Respiratory, LLC, typically indicating an updat…

• FDA label_change · 2016-02-16
  FDA Approved: BREO ELLIPTA — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for BREO ELLIPTA submitted by GlaxoSmithKline LLC to update its labeling.

• FDA label_change · 2016-01-29
  FDA Approved: COMBIVENT RESPIMAT — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  FDA supplemental approval for Combivent Respimat (ipratropium bromide and albuterol) updates the product labeling following Boehringer Ingel…

• FDA label_change · 2015-04-23
  FDA Approved: SPIRIVA HANDIHALER — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Spiriva HandiHaler (tiotropium bromide) from Boehringer Ingelheim, updating the product labeling…

• FDA label_change · 2014-10-17
  FDA Approved: COMBIVENT RESPIMAT — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Combivent Respimat to update the product labeling. Combivent Respimat is a combination inhal…

• FDA label_change · 2014-05-09
  FDA Approved: ATROVENT HFA — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for ATROVENT HFA (ipratropium bromide) from Boehringer Ingelheim Pharmaceuticals, Inc., reflecti…

• FDA label_change · 2012-08-09
  FDA Approved: SEREVENT DISKUS — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for SEREVENT DISKUS (salmeterol xinafoate) from GlaxoSmithKline LLC, resulting in changes to the pro…

• FDA label_change · 2008-06-20
  FDA Approved: SPIRIVA HANDIHALER — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Spiriva HandiHaler (tiotropium bromide) from Boehringer Ingelheim, updating the product labe…