Asthma

• 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 · 2012-08-06
  FDA Approved: MONTELUKAST SODIUM — Original Application (Dr.Reddy's Laboratories Limited)

  FDA approves the original ANDA for Montelukast sodium from Dr. Reddy's Laboratories Limited, establishing a generic Montelukast sodium produ…

• FDA approval · 2012-08-06
  FDA Approved: MONTELUKAST SODIUM — Original Application (Dr.Reddy's Laboratories Limited)

  FDA approved the original application for Montelukast Sodium from Dr. Reddy's Laboratories Limited (ANDA 201581). This approval makes Montel…

• FDA approval · 2012-08-03
  FDA Approved: MONTELUKAST SODIUM — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved the original application for a generic montelukast sodium product from Rising Pharma Holdings, Inc. under ANDA 202468.

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• FDA approval · 2012-08-03
  FDA Approved: MONTELUKAST — Original Application (Sandoz Inc)

  FDA approved Sandoz's original ANDA for montelukast, establishing a generic version of the leukotriene receptor antagonist for prevention of…

• FDA approval · 2012-08-03
  FDA Approved: MONTELUKAST SODIUM — Original Application (Lannett Company, Inc.)

  FDA approves the original application for Montelukast Sodium (generic montelukast) manufactured by Lannett Company, Inc. The approval enable…

• FDA approval · 2012-08-03
  FDA Approved: MONTELUKAST SODIUM — Original Application (Rising Pharma Holdings, Inc.)

  The FDA approved the original application for Montelukast Sodium (generic) from Rising Pharma Holdings, expanding access to montelukast prod…

• FDA approval · 2012-08-03
  FDA Approved: MONTELUKAST SODIUM — Original Application (Torrent Pharmaceuticals Limited)

  FDA approved Torrent Pharmaceuticals Limited's Montelukast Sodium as an original generic application (ANDA 201515).

• FDA approval · 2012-08-03
  FDA Approved: MONTELUKAST SODIUM — Original Application (Torrent Pharmaceuticals Limited)

  FDA approved Torrent Pharmaceuticals Limited's original ANDA for montelukast sodium, establishing a generic version of montelukast for the a…

• FDA approval · 2012-07-31
  FDA Approved: BUDESONIDE INHALATION — Original Application (Amneal Pharmaceuticals of New York LLC)

  The FDA approved Amneal Pharmaceuticals of New York LLC's generic budesonide inhalation under an original ANDA. The product provides a gener…

• 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 · 2012-07-16
  FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)

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

• 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 · 2012-06-08
  FDA Approved: ZYFLO — Supplemental Application (Chiesi USA, Inc.)

  The FDA has approved a supplemental application for ZYFLO (zileuton) from Chiesi USA, Inc., resulting in updated labeling/indications.

• 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 · 2012-03-07
  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 · 2011-12-16
  FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for Singulair (montelukast) by Organon LLC, resulting in an update to the product labeling via a sup…

• FDA approval · 2011-12-16
  FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for Singulair (montelukast sodium) submitted by Organon LLC. The approval updates the product labeli…

• 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…

• FDA approval · 2011-09-27
  FDA Approved: ZAFIRLUKAST — Supplemental Application (Dr. Reddys Laboratories Limited)

  The FDA approved a supplemental application for Zafirlukast submitted by Dr. Reddy's Laboratories Limited.