Bronchospasm

• FDA approval · 2025-12-08
  FDA Approved: EPINEPHRINE — Original Application (Amneal Pharmaceuticals Private Limited)

  The FDA approved Amneal Pharmaceuticals' generic Epinephrine product under an Original Application (ANDA), authorizing its marketing.

• FDA approval · 2024-05-21
  FDA Approved: THEOPHYLLINE — Original Application (Zydus Lifesciences Limited)

  FDA approved an original ANDA for Theophylline by Zydus Lifesciences Limited.

• FDA approval · 2024-05-21
  FDA Approved: ALBUTEROL SULFATE — Original Application (Armstrong Pharmaceuticals, Inc.)

  FDA approved the original generic application for albuterol sulfate from Armstrong Pharmaceuticals, Inc. as a generic bronchodilator. It is …

• FDA approval · 2023-06-23
  FDA Approved: ALBUTEROL SULFATE — Supplemental Application (Luoxin Aurovitas Pharma (Chengdu) Co., Ltd.)

  FDA approved a supplemental application for ALBUTEROL SULFATE from Luoxin Aurovitas Pharma (Chengdu) Co., Ltd. under an ANDA for a generic p…

• 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…

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• FDA approval · 2023-03-08
  FDA Approved: LEVALBUTEROL — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for levalbuterol products from Mylan Pharmaceuticals Inc. under the ANDA program. This action confir…

• FDA approval · 2022-08-15
  FDA Approved: EPINEPHRINE — Original Application (International Medication Systems, Limited)

  FDA approved a new epinephrine product under Original Application NDA211363 from International Medication Systems, Limited.

• FDA approval · 2021-10-28
  FDA Approved: ALBUTEROL SULFATE — Supplemental Application (American Health Packaging)

  FDA approved a supplemental application for albuterol sulfate, a generic inhalation drug, submitted by American Health Packaging.

• FDA approval · 2021-06-01
  FDA Approved: ALBUTEROL SULFATE — Original Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved Hikma Pharmaceuticals USA Inc.'s original application for albuterol sulfate. This approval makes a generic albuterol sulfat…

• FDA approval · 2020-09-29
  FDA Approved: ALBUTEROL SULFATE — Supplemental Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved a supplemental application for ALBUTEROL SULFATE submitted by Padagis Israel Pharmaceuticals Ltd.

• FDA approval · 2020-06-19
  FDA Approved: TERBUTALINE SULFATE — Original Application (Upsher-Smith Laboratories, LLC)

  FDA approval of the original application for Terbutaline Sulfate from Upsher-Smith Laboratories, a generic bronchodilator.

• FDA approval · 2020-05-14
  FDA Approved: ALBUTEROL — Original Application (Aurobindo Pharma Limited)

  FDA approved the original application for ALBUTEROL (albuterol) inhalation product by Aurobindo Pharma Limited.

• FDA approval · 2020-04-08
  FDA Approved: ALBUTEROL SULFATE — Original Application (American Health Packaging)

  FDA approved the original application for albuterol sulfate, a generic product manufactured by American Health Packaging, expanding access t…

• FDA approval · 2020-02-06
  FDA Approved: LEVALBUTEROL — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for levalbuterol from Aurobindo Pharma Limited.

• FDA approval · 2019-09-06
  FDA Approved: ALBUTEROL SULFATE — Original Application (QUAGEN PHARMACEUTICALS LLC)

  FDA approves QUAGEN PHARMACEUTICALS LLC's ALBUTEROL SULFATE original application, granting a generic albuterol sulfate product for relief of…

• FDA approval · 2018-06-29
  FDA Approved: ALBUTEROL — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved the original application for albuterol filed by Rising Pharma Holdings, Inc. under ANDA207046.

• FDA approval · 2017-10-17
  FDA Approved: ALBUTEROL SULFATE — Original Application (Luoxin Aurovitas Pharma (Chengdu) Co., Ltd.)

  FDA approved the original application for albuterol sulfate, a generic inhaled bronchodilator, manufactured by Luoxin Aurovitas Pharma (Chen…

• FDA approval · 2017-08-07
  FDA Approved: IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE — Original Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved Sun Pharmaceutical's original ANDA for ipratropium bromide and albuterol sulfate, a generic inhalation product for treating…

• FDA approval · 2014-10-21
  FDA Approved: TERBUTALINE SULFATE — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for terbutaline sulfate from Fresenius Kabi USA, LLC, indicating an additional authorization related…

• 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 · 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 · 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 · 2009-11-25
  FDA Approved: EPINEPHRINE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  The FDA has approved a supplemental application for Epinephrine from Amneal Pharmaceuticals of New York LLC.

• 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 · 2009-05-20
  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…