Asthma

• FDA approval · 2014-04-14
  FDA Approved: SEREVENT DISKUS — Supplemental Application (GlaxoSmithKline LLC)

  The FDA approved a supplemental application for SEREVENT DISKUS (salmeterol xinafoate) from GlaxoSmithKline LLC. The approval updates or exp…

• FDA approval · 2014-04-14
  FDA Approved: FLUTICASONE PROPIONATE DISKUS — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application to allow Prasco Laboratories to market Fluticasone Propionate Diskus.

• FDA approval · 2014-04-07
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)

  The FDA approved a supplemental application for Montelukast Sodium from Torrent Pharmaceuticals Limited under an ANDA.

• FDA approval · 2014-04-07
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for montelukast sodium from Torrent Pharmaceuticals Limited, granting generic approval under ANDA 20…

• FDA approval · 2014-03-19
  FDA Approved: FORMOTEROL FUMARATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for formoterol fumarate (Mylan Pharmaceuticals Inc.). The action updates the product labeling and ma…

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• FDA approval · 2014-03-07
  FDA Approved: ZAFIRLUKAST — Supplemental Application (Dr. Reddys Laboratories Limited)

  The FDA approved a supplemental application for Zafirlukast submitted by Dr. Reddy's Laboratories Limited. Further details on the nature of …

• FDA approval · 2014-02-27
  FDA Approved: BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for Budesonide and Formoterol Fumarate Dihydrate (Symbicort) from AstraZeneca Pharmaceuticals LP…

• FDA approval · 2014-01-28
  FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)

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

• FDA approval · 2014-01-21
  FDA Approved: VENTOLIN HFA — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for Ventolin HFA (albuterol sulfate) from GlaxoSmithKline, expanding the labeling per the supplement…

• FDA approval · 2014-01-08
  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. This action relates to a regulator…

• FDA approval · 2014-01-03
  FDA Approved: VENTOLIN HFA — Supplemental Application (GlaxoSmithKline LLC)

  FDA approves a supplemental application for Ventolin HFA (albuterol sulfate) filed by GlaxoSmithKline LLC.

• FDA approval · 2013-12-30
  FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)

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

• FDA approval · 2013-11-25
  FDA Approved: XOPENEX HFA — Supplemental Application (Lupin Pharmaceuticals, Inc.)

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

• FDA approval · 2013-11-15
  FDA Approved: ZAFIRLUKAST — Supplemental Application (Strides Pharma Science Limited)

  FDA approved a supplemental application for Zafirlukast from Strides Pharma Science Limited. Zafirlukast is used for the prevention and chro…

• FDA approval · 2013-10-07
  FDA Approved: ALVESCO — Supplemental Application (Covis Pharma US, Inc)

  The FDA approved a supplemental application for ALVESCO (ciclesonide) from Covis Pharma US, Inc., indicating an approval action related to t…

• FDA approval · 2013-09-10
  FDA Approved: XOPENEX HFA — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved a supplemental application for XOPENEX HFA (levalbuterol tartrate) filed by Lupin Pharmaceuticals, Inc.

• FDA approval · 2013-08-23
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Accord Healthcare Inc.)

  The FDA approved a supplemental application for Montelukast Sodium submitted by Accord Healthcare Inc. The snippet does not specify the exac…

• FDA approval · 2013-08-21
  FDA Approved: DULERA — Supplemental Application (Organon LLC)

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

• FDA approval · 2013-08-20
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Lannett Company, Inc.)

  The FDA approved a supplemental ANDA from Lannett Company to market a generic montelukast sodium product. Montelukast is used in the managem…

• FDA approval · 2013-08-14
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for Montelukast sodium from Torrent Pharmaceuticals Limited, formalizing approval of this generic mo…

• FDA approval · 2013-08-06
  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 under an ANDA.

• FDA approval · 2013-08-06
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Dr.Reddy's Laboratories Limited)

  FDA approved a supplemental application for Montelukast Sodium submitted by Dr. Reddy's Laboratories Limited.

• FDA approval · 2013-07-30
  FDA Approved: DULERA — Supplemental Application (Organon LLC)

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

• FDA approval · 2013-06-26
  FDA Approved: MONTELUKAST — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for Montelukast by Sandoz Inc., indicating approval of a change to this generic Montelukast product.…

• FDA approval · 2013-06-19
  FDA Approved: ADVAIR HFA — Supplemental Application (GlaxoSmithKline LLC)

  The FDA granted supplemental approval for ADVAIR HFA (fluticasone propionate and salmeterol xinafoate) by GlaxoSmithKline LLC, updating the …