Chronic Obstructive Pulmonary Disease

• FDA approval · 2017-09-11
  FDA Approved: BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for the budesonide and formoterol fumarate dihydrate inhalation product from AstraZeneca (Symbic…

• FDA approval · 2017-08-07
  FDA Approved: IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE — Original Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved Sun Pharmaceutical's original ANDA for ipratropium bromide and albuterol sulfate, a generic inhalation product for treating…

• FDA approval · 2017-07-21
  FDA Approved: ALBUTEROL SULFATE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical's albuterol sulfate generic under an Original Application; albuterol sulfate is a bronchodilator used to tre…

• FDA approval · 2017-07-19
  FDA Approved: FLUTICASONE PROPIONATE DISKUS — Supplemental Application (Prasco Laboratories)

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

• FDA approval · 2017-06-27
  FDA Approved: DULERA — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for Dulera, a combination inhaled corticosteroid and long-acting beta-agonist, submitted by Organon …

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• FDA approval · 2017-06-13
  FDA Approved: INCRUSE ELLIPTA — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for INCRUSE ELLIPTA (umeclidinium) from GlaxoSmithKline LLC.

• FDA approval · 2017-03-22
  FDA Approved: UMECLIDINIUM AND VILANTEROL ELLIPTA — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for Umeclidinium and Vilanterol Ellipta (umeclidinium bromide and vilanterol trifenatate) submitted …

• FDA approval · 2017-02-28
  FDA Approved: ADVAIR DISKUS — Supplemental Application (GlaxoSmithKline LLC)

  FDA granted a supplemental approval for Advair Diskus (fluticasone propionate and salmeterol) by GlaxoSmithKline LLC.

• FDA approval · 2017-02-28
  FDA Approved: ADVAIR HFA — Supplemental Application (GlaxoSmithKline LLC)

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

• FDA approval · 2017-02-27
  FDA Approved: XOPENEX HFA — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for XOPENEX HFA (levalbuterol tartrate).

• FDA approval · 2017-02-15
  FDA Approved: SPIRIVA RESPIMAT — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Spiriva Respimat (tiotropium bromide inhalation spray) from Boehringer Ingelheim Pharmaceuti…

• FDA approval · 2017-01-31
  FDA Approved: LEVALBUTEROL — Original Application (Aurobindo Pharma Limited)

  The FDA approved an original ANDA for Levalbuterol from Aurobindo Pharma Limited, providing a generic option for this bronchodilator.

• FDA approval · 2017-01-27
  FDA Approved: FLUTICASONE PROPIONATE AND SALMETEROL — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva's Fluticasone Propionate and Salmeterol under an Original Application (NDA208799), a fixed-dose inhaled corticosteroid/lon…

• FDA approval · 2017-01-27
  FDA Approved: BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approved a supplemental application for budesonide and formoterol fumarate dihydrate to update the product labeling for AstraZeneca's in…

• FDA approval · 2017-01-03
  FDA Approved: IPRATROPIUM BROMIDE — Original Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved Sun Pharmaceutical's ipratropium bromide as an original generic drug (ANDA approval).

• FDA approval · 2016-12-30
  FDA Approved: LEVALBUTEROL — Original Application (Aurobindo Pharma Limited)

  FDA approved the original ANDA for levalbuterol manufactured by Aurobindo Pharma Limited.

• FDA approval · 2016-12-16
  FDA Approved: THEOPHYLLINE — Original Application (PAI Holdings, LLC dba PAI Pharma)

  FDA approves the original generic application for theophylline from PAI Holdings/PAI Pharma, authorizing the sale of a generic theophylline …

• FDA approval · 2016-10-05
  FDA Approved: FLUTICASONE PROPIONATE DISKUS — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application for Fluticasone Propionate Diskus submitted by Prasco Laboratories, authorizing the marketing of…

• FDA approval · 2016-09-30
  FDA Approved: SEREVENT DISKUS — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for SEREVENT DISKUS (salmeterol xinafoate) from GlaxoSmithKline LLC, indicating an approved change t…

• FDA approval · 2016-08-11
  FDA Approved: ATROVENT HFA — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Atrovent HFA (ipratropium bromide) submitted by Boehringer Ingelheim Pharmaceuticals, Inc., …

• FDA approval · 2016-07-12
  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 · 2016-06-23
  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, I…

• FDA approval · 2016-06-17
  FDA Approved: COMBIVENT RESPIMAT — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Combivent Respimat (ipratropium bromide and albuterol) submitted by Boehringer Ingelheim Pharmac…

• FDA approval · 2016-06-09
  FDA Approved: COMBIVENT RESPIMAT — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Combivent Respimat (ipratropium bromide and albuterol) from Boehringer Ingelheim Pharmaceuticals…

• FDA approval · 2016-06-09
  FDA Approved: STRIVERDI RESPIMAT — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Striverdi Respimat (olodaterol inhalation spray) from Boehringer Ingelheim Pharmaceuticals, Inc.…