Asthma

• FDA approval · 2010-11-18
  FDA Approved: ZAFIRLUKAST — Original Application (Dr. Reddys Laboratories Limited)

  The FDA approved a generic version of zafirlukast from Dr. Reddys Laboratories Limited under an Original Application (ANDA). It covers the u…

• FDA approval · 2010-10-27
  FDA Approved: THEOPHYLLINE — Original Application (Alembic Pharmaceuticals Limited)

  FDA approved Alembic Pharmaceuticals Limited's Theophylline as an Original Application (ANDA) product, making it a generic version of theoph…

• FDA approval · 2010-10-13
  FDA Approved: ZAFIRLUKAST — Supplemental Application (Strides Pharma Science Limited)

  FDA approved a supplemental application for Zafirlukast submitted by Strides Pharma Science Limited, confirming an approved modification to …

• FDA approval · 2010-10-05
  FDA Approved: ARIDOL BRONCHIAL CHALLENGE TEST KIT — Original Application (Methapharm, Inc.)

  The FDA approved the ARIDOL BRONCHIAL CHALLENGE TEST KIT (mannitol) from Methapharm, Inc. under an original NDA to aid in diagnosing asthma …

• FDA approval · 2010-09-17
  FDA Approved: ASMANEX — Supplemental Application (Organon LLC)

  The FDA approved a supplemental application for ASMANEX (mometasone furoate) from Organon LLC.

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• FDA approval · 2010-08-17
  FDA Approved: ALBUTEROL SULFATE HFA — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Albuterol Sulfate HFA submitted by Teva Pharmaceuticals USA, Inc., potentially updating labeling…

• FDA approval · 2010-08-10
  FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for Singulair (montelukast) filed by Organon LLC, resulting in labeling changes to reflect the suppl…

• FDA approval · 2010-07-14
  FDA Approved: ZAFIRLUKAST — Supplemental Application (Strides Pharma Science Limited)

  FDA approved a supplemental application for Zafirlukast from Strides Pharma Science Limited.

• FDA approval · 2010-07-13
  FDA Approved: THEOPHYLLINE — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's Theophylline from an Original Application; Theophylline is a bronchodilator used to treat symptoms of obstructive ai…

• FDA approval · 2010-07-02
  FDA Approved: PULMICORT FLEXHALER — Supplemental Application (H2-Pharma LLC)

  FDA approved a supplemental application for Pulmicort Flexhaler (budesonide) submitted by H2-Pharma LLC.

• FDA approval · 2010-07-02
  FDA Approved: PULMICORT RESPULES — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approved a supplemental application for Pulmicort Respules (budesonide) to update/expand the product labeling.

• 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 · 2010-06-22
  FDA Approved: DULERA — Original Application (Organon LLC)

  FDA approves the original application for DULERA, a fixed-dose inhaled corticosteroid/long-acting beta-agonist combination (mometasone furoa…

• 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.

• 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 · 2009-08-21
  FDA Approved: ZAFIRLUKAST — Supplemental Application (Strides Pharma Science Limited)

  FDA approved a supplemental application for Zafirlukast submitted by Strides Pharma Science Limited.

• FDA approval · 2009-08-19
  FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)

  FDA approved a Supplemental Application for Singulair (montelukast sodium) submitted by Organon LLC. This action typically results in labeli…

• FDA approval · 2009-08-19
  FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)

  The FDA approved a supplemental application for Singulair (montelukast) submitted by Organon LLC.

• 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,…