Chronic Obstructive Pulmonary Disease

• FDA approval · 2013-01-15
  FDA Approved: DULERA — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for Dulera (mometasone furoate and formoterol fumarate dihydrate) from Organon LLC.

• FDA approval · 2013-01-09
  FDA Approved: XOPENEX HFA — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for XOPENEX HFA (levalbuterol tartrate), resulting in an approved labeling upda…

• FDA approval · 2013-01-09
  FDA Approved: COMBIVENT RESPIMAT — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

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

• FDA approval · 2012-12-19
  FDA Approved: ADVAIR HFA — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for Advair HFA (fluticasone propionate and salmeterol xinafoate) from GlaxoSmithKline LLC, indicatin…

• FDA approval · 2012-12-18
  FDA Approved: DALIRESP — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for Daliresp (rofllumilast) from AstraZeneca Pharmaceuticals LP, resulting in an updated product…

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• FDA approval · 2012-12-10
  FDA Approved: ALBUTEROL SULFATE HFA — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for Albuterol Sulfate HFA from Teva, updating or expanding the labeling for the inhalation produ…

• FDA approval · 2012-12-07
  FDA Approved: XOPENEX HFA — Supplemental Application (Lupin Pharmaceuticals, Inc.)

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

• FDA approval · 2012-11-23
  FDA Approved: DULERA — Supplemental Application (Organon LLC)

  The FDA approved a supplemental application for Dulera (mometasone furoate and formoterol fumarate dihydrate) from Organon LLC, updating the…

• FDA approval · 2012-10-01
  FDA Approved: IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE — Original Application (Golden State Medical Supply, Inc.)

  FDA approves the original application for a generic ipratropium bromide and albuterol sulfate inhalation product by Golden State Medical Sup…

• FDA approval · 2012-09-06
  FDA Approved: VENTOLIN HFA — Supplemental Application (GlaxoSmithKline LLC)

  The FDA approved a supplemental application for Ventolin HFA (albuterol sulfate) from GlaxoSmithKline.

• FDA approval · 2012-08-29
  FDA Approved: COMBIVENT RESPIMAT — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

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

• FDA approval · 2012-08-13
  FDA Approved: IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE — Supplemental Application (Nephron Pharmaceuticals Corporation)

  FDA approved a supplemental application for the combination inhaler ipratropium bromide and albuterol sulfate from Nephron Pharmaceuticals C…

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

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

• FDA approval · 2012-08-09
  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 to…

• FDA approval · 2012-07-30
  FDA Approved: XOPENEX HFA — Supplemental Application (Lupin Pharmaceuticals, Inc.)

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

• FDA approval · 2012-07-23
  FDA Approved: BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approved a supplemental application for Budesonide and Formoterol Fumarate Dihydrate, submitted by AstraZeneca Pharmaceuticals LP.

• FDA approval · 2012-07-23
  FDA Approved: TUDORZA PRESSAIR — Original Application (Covis Pharma US, Inc)

  FDA approved Tudorza Pressair (aclidinium bromide) through an Original Application (NDA) submitted by Covis Pharma US, Inc.

• FDA approval · 2012-06-15
  FDA Approved: THEOPHYLLINE — Original Application (Cranbury Pharmaceuticals, LLC)

  FDA approval of an original application (ANDA) for Theophylline from Cranbury Pharmaceuticals, LLC, indicating a generic product approval.

• FDA approval · 2012-06-05
  FDA Approved: ALBUTEROL SULFATE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for albuterol sulfate by Sandoz Inc under NDA 020503, signaling an approved modification to the exis…

• FDA approval · 2012-05-08
  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, ap…

• FDA approval · 2012-04-11
  FDA Approved: DALIRESP — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for DalireSP (roflumilast) submitted by AstraZeneca Pharmaceuticals LP.

• FDA approval · 2012-03-07
  FDA Approved: ALBUTEROL SULFATE HFA — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a Teva supplemental application for Albuterol Sulfate HFA, indicating an approved change to the product’s NDA (e.g., labeling o…

• FDA approval · 2012-02-06
  FDA Approved: IPRATROPIUM BROMIDE — Supplemental Application (Oceanside Pharmaceuticals)

  The FDA approved a supplemental application for ipratropium bromide submitted by Oceanside Pharmaceuticals.

• FDA approval · 2011-12-13
  FDA Approved: IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE — Supplemental Application (Nephron Pharmaceuticals Corporation)

  The FDA approved a supplemental application for a generic ipratropium bromide and albuterol sulfate inhalation product from Nephron Pharmace…

• FDA approval · 2011-10-14
  FDA Approved: THEOPHYLLINE ANHYDROUS — Supplemental Application (Rhodes Pharmaceuticals L.P.)

  FDA approved a supplemental application for Theophylline Anhydrous by Rhodes Pharmaceuticals, indicating approval of a supplement to the pro…