Chronic Obstructive Pulmonary Disease

• FDA approval · 2021-06-22
  FDA Approved: ARFORMOTEROL TARTRATE — Original Application (Cipla USA Inc.)

  FDA approves Cipla USA's original application for arformoterol tartrate, a generic long-acting beta-agonist for maintenance treatment of chr…

• FDA approval · 2021-06-03
  FDA Approved: THEOPHYLLINE — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's Theophylline as a new original ANDA, enabling a generic Theophylline product. Theophylline is a bronchodilator used …

• 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 · 2021-03-31
  FDA Approved: BUDESONIDE INHALATION — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved a supplemental application for Budesonide Inhalation by Amneal Pharmaceuticals of New York LLC.

• 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 · 2020-12-17
  FDA Approved: FLUTICASONE PROPIONATE AND SALMETEROL — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approves Hikma's generic inhalation powder combination of fluticasone propionate and salmeterol. It is indicated for the treatment of as…

• FDA approval · 2020-11-05
  FDA Approved: BEVESPI AEROSPHERE — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for Bevespi Aerosphere from AstraZeneca Pharmaceuticals LP.

• FDA approval · 2020-10-22
  FDA Approved: ALBUTEROL — Original Application (Zydus Pharmaceuticals USA Inc.)

  FDA approves the original application for ALBUTEROL by Zydus Pharmaceuticals USA Inc., establishing a generic albuterol product.

• FDA approval · 2020-09-29
  FDA Approved: PROAIR DIGIHALER — Supplemental Application (Teva Respiratory, LLC)

  FDA approved a supplemental application for ProAir Digihaler (albuterol sulfate) from Teva Respiratory, LLC.

• 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 · 2020-09-27
  FDA Approved: COMBIVENT RESPIMAT — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Combivent Respimat, a combination inhaler of ipratropium bromide and albuterol, from Boehringer …

• FDA approval · 2020-09-02
  FDA Approved: PREDNISONE — Original Application (Strides Pharma Science Limited)

  FDA approval of a generic prednisone (PREDNISONE) Original Application by Strides Pharma Science Limited.

• FDA approval · 2020-08-24
  FDA Approved: ALBUTEROL SULFATE — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' original ANDA for albuterol sulfate, authorizing the marketing of a generic albuterol sulfate product.

• FDA approval · 2020-07-23
  FDA Approved: BREZTRI — Original Application (AstraZeneca Pharmaceuticals LP)

  FDA granted original approval for BREZTRI, a triple inhaled therapy (budesonide/glycopyrrolate/formoterol fumarate) from AstraZeneca for the…

• FDA approval · 2020-07-09
  FDA Approved: IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE — Original Application (Aurobindo Pharma Limited)

  FDA approved Aurobindo Pharma's original ANDA for a generic combination of ipratropium bromide and albuterol sulfate.

• 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 · 2020-04-20
  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 · 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 · 2020-02-24
  FDA Approved: ALBUTEROL SULFATE — Original Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved Padagis Israel Pharmaceuticals Ltd's original ANDA for albuterol sulfate. The product is a generic inhaled bronchodilator indic…

• FDA approval · 2020-02-21
  FDA Approved: FLUTICASONE PROPIONATE AND SALMETEROL — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Fluticasone Propionate and Salmeterol from Teva, updating the product's labeling (e.g., indicati…

• FDA approval · 2020-02-07
  FDA Approved: LEVALBUTEROL — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for Levalbuterol submitted by Aurobindo Pharma Limited.

• 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 · 2019-12-20
  FDA Approved: LEVALBUTEROL INHALATION SOLUTION — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental ANDA for Levalbuterol Inhalation Solution from Sun Pharmaceutical Industries, granting generic approval for this…

• FDA approval · 2019-12-16
  FDA Approved: VENTOLIN HFA — Supplemental Application (GlaxoSmithKline LLC)

  The FDA approved GlaxoSmithKline LLC's supplemental application for Ventolin HFA (albuterol sulfate) under NDA 020983, resulting in a regula…