Asthma

• 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: ALBUTEROL SULFATE HFA — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for ALBUTEROL SULFATE HFA from Teva Pharmaceuticals USA, Inc., related to this albuterol sulfate…

• 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 · 2012-12-17
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Accord Healthcare Inc.)

  FDA approved a supplemental application for Montelukast Sodium by Accord Healthcare Inc., resulting in an approved modification to the produ…

• FDA approval · 2012-12-13
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for montelukast sodium filed by Rising Pharma Holdings, Inc., indicating approval of a change or add…

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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 · 2012-12-10
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Dr.Reddy's Laboratories Limited)

  FDA approved the supplemental application for Montelukast Sodium from Dr. Reddy's Laboratories Limited, granting approval for this generic m…

• FDA approval · 2012-12-10
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Dr.Reddy's Laboratories Limited)

  FDA approved a supplemental application for Montelukast Sodium from Dr.Reddy's Laboratories Limited (ANDA201581).

• 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 · 2012-12-05
  FDA Approved: FLUTICASONE PROPIONATE DISKUS — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for Fluticasone Propionate Diskus from Prasco Laboratories, approving a generic version of the inhal…

• FDA approval · 2012-11-30
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for Montelukast Sodium by Rising Pharma Holdings, Inc., enabling a generic version of Montelukast so…

• 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 · 2012-11-19
  FDA Approved: ALVESCO — Supplemental Application (Covis Pharma US, Inc)

  FDA approved a supplemental application for ALVESCO (ciclesonide) from Covis Pharma US, Inc., resulting in updated labeling for the product.

• FDA approval · 2012-10-18
  FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)

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

• FDA approval · 2012-10-18
  FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)

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

• FDA approval · 2012-10-16
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for montelukast sodium from Torrent Pharmaceuticals Limited, enabling the generic product to be mark…

• FDA approval · 2012-10-16
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for Montelukast Sodium from Torrent Pharmaceuticals Limited.

• 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 · 2012-09-27
  FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)

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

• FDA approval · 2012-09-27
  FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)

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

• FDA approval · 2012-09-21
  FDA Approved: MONTELUKAST SODIUM — Original Application (Accord Healthcare Inc.)

  FDA approved Accord Healthcare Inc.'s Montelukast Sodium Original Application under ANDA 202717, granting a generic version of montelukast s…

• FDA approval · 2012-09-18
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Lannett Company, Inc.)

  FDA approved a supplemental application for montelukast sodium from Lannett Company, Inc., indicating approval of a supplemental (generic) f…

• 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 · 2012-08-21
  FDA Approved: DULERA — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for Dulera (mometasone furoate/formoterol fumarate dihydrate) submitted by Organon LLC.

• 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…