Chronic Obstructive Pulmonary Disease
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Sign up freeTop drugs studied for this disease
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FDA approval · 2023-06-20FDA Approved: TIOTROPIUM BROMIDE — Original Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals' generic tiotropium bromide (ANDA) through an Original Application for the maintenance treatment of chron…
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FDA approval · 2023-06-06FDA Approved: ROFLUMILAST — Supplemental Application (Solco Healthcare US, LLC.)
The FDA approved a supplemental application for a generic roflumilast product from Solco Healthcare US, LLC. This approval makes a generic C…
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FDA approval · 2023-06-02FDA Approved: UMECLIDINIUM AND VILANTEROL ELLIPTA — Supplemental Application (Prasco Laboratories)
FDA approves a supplemental application from Prasco Laboratories for UMECLIDINIUM AND VILANTEROL ELLIPTA (umeclidinium bromide and vilantero…
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FDA approval · 2023-05-28FDA Approved: ALBUTEROL SULFATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approves a supplemental application for albuterol sulfate from Sun Pharmaceutical Industries, updating the status of this generic produc…
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FDA approval · 2023-05-12FDA Approved: BREO ELLIPTA — Supplemental Application (GlaxoSmithKline LLC)
FDA approved a supplemental application for BREO ELLIPTA submitted by GlaxoSmithKline. The approval pertains to changes to the product's lab…
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FDA approval · 2023-05-08FDA 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 · 2023-04-26FDA Approved: THEOPHYLLINE — Original Application (Bionpharma Inc.,)
FDA approves Bionpharma Inc.’s Theophylline generic under an Original Application (ANDA). The product is approved for use in asthma and chro…
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FDA approval · 2023-04-18FDA Approved: ROFLUMILAST — Original Application (Ascend Laboratories, LLC)
FDA approved an original ANDA for roflumilast from Ascend Laboratories, making a generic version of this COPD medication available.
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FDA approval · 2023-04-18FDA Approved: ROFLUMILAST — Original Application (Zydus Pharmaceuticals USA Inc.)
FDA approved the original ANDA for a generic roflumilast from Zydus Pharmaceuticals USA Inc., enabling a generic version of the COPD medicat…
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FDA approval · 2023-04-17FDA Approved: ROFLUMILAST — Original Application (Aurobindo Pharma Limited)
FDA approved an original application for roflumilast from Aurobindo Pharma Limited, enabling a generic version of the COPD medication.
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FDA approval · 2023-04-12FDA Approved: LEVALBUTEROL — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for levalbuterol by Mylan Pharmaceuticals, approving a change to the product under ANDA 078309.
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FDA approval · 2023-04-04FDA Approved: ROFLUMILAST — Supplemental Application (Camber Pharmaceuticals, Inc.)
FDA approved Camber Pharmaceuticals' supplemental ANDA for roflumilast (generic roflumilast), expanding access to this COPD treatment as a g…
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FDA approval · 2023-03-22FDA Approved: FORMOTEROL FUMARATE — Original Application (Lifestar Pharma LLC)
FDA approves the original application for Formoterol fumarate dihydrate supplied by Lifestar Pharma LLC. This generic product is approved fo…
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FDA approval · 2023-03-20FDA Approved: THEOPHYLLINE — Original Application (Amneal Pharmaceuticals NY LLC)
FDA approved Amneal's Theophylline (generic) under an Original Application (ANDA 216276). Theophylline is indicated for relief of bronchospa…
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FDA approval · 2023-03-08FDA 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…
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FDA approval · 2023-03-01FDA Approved: FLUTICASONE FUROATE ELLIPTA — Supplemental Application (Prasco Laboratories)
FDA approved a supplemental application for Fluticasone Furoate Ellipta from Prasco Laboratories.
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FDA approval · 2023-02-08FDA Approved: FLUTICASONE PROPIONATE AND SALMETEROL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for a generic inhaled fixed-dose combination of fluticasone propionate and salmeterol by Hikma P…
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FDA approval · 2023-01-30FDA Approved: THEOPHYLLINE — Original Application (Leading Pharma, LLC)
FDA approved Leading Pharma, LLC's original ANDA for theophylline, authorizing a generic version of theophylline. The approval supports its …
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FDA approval · 2023-01-26FDA Approved: BREZTRI — Supplemental Application (AstraZeneca Pharmaceuticals LP)
FDA approved a supplemental application for BREZTRI (budesonide, glycopyrrolate, and formoterol fumarate) from AstraZeneca, indicating an ap…
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FDA approval · 2022-12-21FDA Approved: ARFORMOTEROL TARTRATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved Sun Pharmaceutical Industries' supplemental application for arformoterol tartrate, a generic inhaled long-acting beta-agonist u…
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FDA approval · 2022-11-25FDA Approved: FORMOTEROL FUMARATE INHALATION SOLUTION — Original Application (Ritedose Pharmaceuticals, LLC)
The FDA approved an abbreviated new drug application for Formoterol Fumarate Inhalation Solution from Ritedose Pharmaceuticals as a generic …
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FDA approval · 2022-11-15FDA Approved: ARFORMOTEROL TARTRATE — Original Application (Lifestar Pharma LLC)
FDA approved the Original Application for ARFORMOTEROL TARTRATE (arformoterol tartrate) by Lifestar Pharma LLC as a generic inhalation produ…
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FDA approval · 2022-10-20FDA Approved: UMECLIDINIUM AND VILANTEROL ELLIPTA — Supplemental Application (Prasco Laboratories)
FDA approved a supplemental application for Umeclidinium bromide and vilanterol triflate Ellipta, submitted by Prasco Laboratories.
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FDA approval · 2022-10-12FDA Approved: THEOPHYLLINE — Original Application (Teva Pharmaceuticals, Inc.)
The FDA approved an original application for a generic Theophylline product from Teva Pharmaceuticals.
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FDA approval · 2022-09-07FDA Approved: ROFLUMILAST — Original Application (Novadoz Pharmaceuticals LLC)
The FDA approved Novadoz Pharmaceuticals LLC's original application for roflumilast, enabling a generic version of the COPD medication to en…