Cough

• FDA approval · 2011-04-20
  FDA Approved: BENZONATATE — Supplemental Application (Bionpharma Inc.)

  FDA approved a supplemental application for BENZONATATE from Bionpharma Inc., confirming an additional approval for this generic cough suppr…

• FDA approval · 2011-04-20
  FDA Approved: HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE — Original Application (Lupin Pharmaceuticals,Inc.)

  FDA approved Lupin Pharmaceuticals' generic hydrocodone bitartrate and homatropine methylbromide tablet, an opioid antitussive indicated for…

• FDA approval · 2011-03-03
  FDA Approved: BENZONATATE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for Benzonatate by Zydus Pharmaceuticals USA Inc., authorizing changes under the ANDA.

• FDA approval · 2011-03-01
  FDA Approved: BENZONATATE — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for BENZONATATE submitted by Amneal Pharmaceuticals LLC.

• CLINICAL_TRIALS research · 2010-11-24
  Clinical Trial Update: Measurement of Exhaled Nitric Oxide (NO) and Bronchial Provocation Test With Mannitol as a Predictor of Response to Inhaled Corticosteroids in Chronic Cough [NA]

  This clinical trial update describes a study evaluating whether exhaled nitric oxide measurements and a Mannitol bronchial provocation test …

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• FDA approval · 2010-10-01
  FDA Approved: HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX EXTENDED-RELEASE — Original Application (Cranbury Pharmaceuticals, LLC)

  FDA approved the original application for Hydrocodone polistirex and chlorpheniramine polistirex extended-release, a fixed-dose combination …

• FDA approval · 2010-04-06
  FDA Approved: BENZONATATE — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approved a supplemental application for BENZONATATE from Amneal Pharmaceuticals LLC under an ANDA. The action approves changes submi…

• CLINICAL_TRIALS trial_result · 2010-03-10
  Clinical Trial Update: Capsaicin Cough Threshold in Chronic Cough Due to Postnasal Drip

  Mayo Clinic conducted a study to measure the cough threshold to capsaicin in individuals with chronic cough due to postnasal drip, and the r…

• FDA approval · 2009-10-08
  FDA Approved: DELSYM — Supplemental Application (RB Health (US) LLC)

  FDA approved a supplemental application for Delsym (dextromethorphan) submitted by RB Health (US) LLC.

• CLINICAL_TRIALS trial_result · 2009-07-02
  Clinical Trial Update: Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of AG1321001 in Chronic Cougher [Phase 3]

  A Phase 3 confirmatory trial evaluating the safety and efficacy of AG1321001 for chronic cough has completed.

• CLINICAL_TRIALS trial_result · 2009-01-12
  Clinical Trial Update: A Phase II Clinical Study of PDC-748 in Patients With Acute Cough [Phase 2]

  Phase II clinical study evaluating PDC-748 for acute cough has completed; the update does not provide detailed results.

• FDA approval · 2008-12-05
  FDA Approved: DELSYM — Supplemental Application (RB Health (US) LLC)

  FDA approves a supplemental application for Delsym (dextromethorphan) filed by RB Health (US) LLC.

• FDA approval · 2008-04-02
  FDA Approved: PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Promethazine hydrochloride and dextromethorphan hydrobromide by ANI Pharmaceuticals Inc.

• FDA approval · 2007-10-30
  FDA Approved: BENZONATATE — Supplemental Application (Bionpharma Inc.)

  FDA approved a supplemental application for Benzonatate by Bionpharma Inc. (ANDA 081297), resulting in supplemental approval for the generic…

• FDA approval · 2007-06-08
  FDA Approved: BENZONATATE — Original Application (Zydus Pharmaceuticals USA Inc.)

  FDA approves the original application for benzonatate from Zydus Pharmaceuticals USA Inc.

• FDA approval · 2007-03-30
  FDA Approved: BENZONATATE — Original Application (Ascend Laboratories, LLC)

  FDA approved Ascend Laboratories' original ANDA for benzonatate tablets, establishing a generic version of the antitussive for relief of cou…