Exercise-induced Bronchospasm

• FDA approval · 2025-12-01
  FDA Approved: ALBUTEROL SULFATE INHALATION — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approved Amneal's albuterol sulfate inhalation as a generic inhalation product under ANDA 211600 for relief of bronchospasm in reversibl…

• FDA approval · 2024-05-03
  FDA Approved: ALBUTEROL SULFATE — Original Application (Ingenus Pharmaceuticals, LLC)

  FDA approves Ingenus Pharmaceuticals' original application for albuterol sulfate as a generic inhalation product. The approved indication co…

• FDA approval · 2023-08-28
  FDA Approved: PROAIR DIGIHALER — Supplemental Application (Teva Respiratory, LLC)

  FDA approved a supplemental application for ProAir Digihaler (albuterol sulfate) from Teva Respiratory, LLC. The approval covers changes rel…

• FDA approval · 2023-05-08
  FDA Approved: ALBUTEROL SULFATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for albuterol sulfate submitted by Mylan Pharmaceuticals Inc. under ANDA214531. This action adds…

• FDA approval · 2021-01-14
  FDA Approved: ALBUTEROL SULFATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved a supplemental application from Lupin Pharmaceuticals for albuterol sulfate, confirming approval of a generic inhalation produc…

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• FDA approval · 2020-04-20
  FDA Approved: ALBUTEROL SULFATE — Original Application (Luoxin Aurovitas Pharma (Chengdu) Co., Ltd.)

  The FDA approved an original application for a generic albuterol sulfate product by Luoxin Aurovitas Pharma (Chengdu) Co., Ltd., authorizing…

• FDA approval · 2019-03-15
  FDA Approved: ALBUTEROL — Original Application (Nivagen Pharmaceuticals Inc)

  FDA approves the original ANDA for albuterol sulfate (albuterol) from Nivagen Pharmaceuticals Inc, making a generic albuterol product availa…

• FDA approval · 2019-01-09
  FDA Approved: PROAIR DIGIHALER — Supplemental Application (Teva Respiratory, LLC)

  The FDA approved a supplemental application for PROAIR DIGIHALER (albuterol sulfate) submitted by Teva Respiratory, LLC. This action updates…

• FDA approval · 2018-05-21
  FDA Approved: ALBUTEROL — Original Application (Amneal Pharmaceuticals NY LLC)

  The FDA approved the original application for albuterol from Amneal Pharmaceuticals NY LLC, enabling a generic albuterol inhalation product …

• FDA approval · 2015-08-14
  FDA Approved: VENTOLIN HFA — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for Ventolin HFA (albuterol sulfate) from GlaxoSmithKline LLC.

• FDA approval · 2014-06-17
  FDA Approved: VENTOLIN HFA — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for Ventolin HFA (albuterol sulfate) submitted by GlaxoSmithKline LLC.

• FDA approval · 2013-04-04
  FDA Approved: CROMOLYN SODIUM — Original Application (Micro Labs Limited)

  FDA approved Micro Labs Limited's original ANDA for cromolyn sodium.

• FDA approval · 2013-02-19
  FDA Approved: LEVALBUTEROL — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application from Mylan Pharmaceuticals Inc. for Levalbuterol, confirming the availability of a generic bronc…

• 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 · 2012-06-05
  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 · 2010-12-10
  FDA Approved: ALBUTEROL SULFATE HFA — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva's supplemental application for Albuterol Sulfate HFA inhalation aerosol.

• 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 · 2008-12-16
  FDA Approved: ALBUTEROL SULFATE — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approved Mylan Pharmaceuticals' original application for ALBUTEROL SULFATE as a generic product. Albuterol sulfate is a bronchodilator i…

• FDA approval · 2008-09-16
  FDA Approved: ALBUTEROL SULFATE HFA — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for ALBUTEROL SULFATE HFA by Teva Pharmaceuticals USA, Inc., updating the product label through a su…

• 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.

• 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…