Chronic Obstructive Pulmonary Disease

• FDA approval · 2007-12-31
  FDA Approved: IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE — Original Application (Nephron Pharmaceuticals Corporation)

  The FDA approved Nephron Pharmaceuticals' original application for a generic ipratropium bromide and albuterol sulfate combination inhaler f…

• FDA approval · 2007-12-31
  FDA Approved: IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE — Original Application (Cipla USA Inc.)

  The FDA approved Cipla USA Inc.'s original application for a generic ipratropium bromide and albuterol sulfate inhalation product.

• FDA approval · 2007-10-31
  FDA Approved: BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approved a supplemental application for budesonide/formoterol fumarate dihydrate (Symbicort) from AstraZeneca Pharmaceuticals LP. The ac…

• FDA approval · 2007-10-26
  FDA Approved: BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for Budesonide and Formoterol Fumarate Dihydrate from AstraZeneca, updating the product’s labeli…

• FDA approval · 2007-06-26
  FDA Approved: ALBUTEROL SULFATE — Original Application (Chartwell RX, LLC)

  FDA approved a generic albuterol sulfate product under an Original Application for Chartwell RX, LLC.

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• FDA approval · 2007-05-22
  FDA Approved: IPRATROPIUM BROMIDE — Supplemental Application (Apotex Corp.)

  The FDA approved a supplemental application from Apotex Corp. for ipratropium bromide.

• FDA approval · 2007-05-11
  FDA Approved: FORMOTEROL FUMARATE — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approved the original application for Formoterol Fumarate Dihydrate (FORMOTEROL FUMARATE) by Mylan Pharmaceuticals Inc., a long-acting b…

• FDA approval · 2007-03-29
  FDA Approved: ALBUTEROL SULFATE — Supplemental Application (Chartwell RX, LLC.)

  The FDA approved a supplemental application for albuterol sulfate from Chartwell RX, LLC., updating an existing generic product.

• FDA approval · 2007-03-28
  FDA Approved: ALBUTEROL SULFATE — Supplemental Application (Nephron Pharmaceuticals Corporation)

  FDA approved a supplemental application for albuterol sulfate from Nephron Pharmaceuticals Corporation under an abbreviated new drug applica…

• FDA approval · 2007-02-23
  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 · 2007-02-23
  FDA Approved: SEREVENT DISKUS — Supplemental Application (GlaxoSmithKline LLC)

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

• FDA approval · 2006-12-08
  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 · 2006-09-20
  FDA Approved: SPIRIVA HANDIHALER — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  FDA approves a supplemental application for SPIRIVA HANDIHALER (tiotropium bromide) submitted by Boehringer Ingelheim Pharmaceuticals, Inc.

• FDA approval · 2006-09-15
  FDA Approved: XOPENEX HFA — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for XOPENEX HFA (levalbuterol tartrate). The approval relates to changes descri…

• FDA approval · 2006-09-05
  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.

• FDA approval · 2006-07-21
  FDA Approved: BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE — Original Application (AstraZeneca Pharmaceuticals LP)

  FDA approved the original application for budesonide and formoterol fumarate dihydrate (Symbicort) from AstraZeneca Pharmaceuticals LP, a co…

• FDA approval · 2006-06-08
  FDA Approved: ADVAIR HFA — Original Application (GlaxoSmithKline LLC)

  This document records the original FDA approval of Advair HFA, a combination inhaled therapy of fluticasone propionate and salmeterol xinafo…