Bronchitis

• FDA approval · 2025-04-15
  FDA Approved: RUGBY MUCUS RELIEF ER — Supplemental Application (Rugby Laboratories)

  FDA approved a supplemental application for Rugby Mucus Relief ER (guaifenesin) from Rugby Laboratories, allowing the generic product to be …

• FDA approval · 2025-03-14
  FDA Approved: ACETYLCYSTEINE — Original Application (Cameron Pharmaceuticals)

  FDA approves Cameron Pharmaceuticals' Acetylcysteine original application (ANDA 214177). Acetylcysteine is used as a mucolytic and as an ant…

• FDA approval · 2025-02-21
  FDA Approved: SULFAMETHOXAZOLE AND TRIMETHOPRIM — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application from Prasco Laboratories for sulfamethoxazole and trimethoprim, granting approval of a generic p…

• FDA approval · 2025-02-12
  FDA Approved: ACETYLCYSTEINE — Original Application (Somerset Therapeutics, LLC)

  FDA approved the original application for acetylcysteine from Somerset Therapeutics, LLC, granting approval for a generic acetylcysteine pro…

• FDA approval · 2024-09-05
  FDA Approved: THEOPHYLLINE — Original Application (Strides Pharma Science Limited)

  FDA approves a generic Theophylline from Strides Pharma Science Limited via an Original Application (ANDA).

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• FDA approval · 2024-07-11
  FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Supplemental Application (Micro Labs Limited)

  FDA approved a supplemental application for Amoxicillin and Clavulanate Potassium from Micro Labs Limited under ANDA217805.

• FDA approval · 2024-06-24
  FDA Approved: SULFAMETHOXAZOLE AND TRIMETHOPRIM — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for sulfamethoxazole and trimethoprim by Prasco Laboratories. This action confirms the approval of t…

• 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 · 2023-09-13
  FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Original Application (Devatis Inc.)

  FDA approved a generic Amoxicillin and clavulanate potassium product under Original Application by Devatis Inc.

• FDA approval · 2023-06-06
  FDA 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…

• FDA approval · 2023-03-20
  FDA 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…

• FDA approval · 2022-11-02
  FDA Approved: AMOXICILLIN — Supplemental Application (USAntibiotics, LLC)

  FDA approved a supplemental application for Amoxicillin submitted by USAntibiotics, LLC.

• FDA approval · 2022-05-10
  FDA Approved: ROFLUMILAST — Original Application (Solco Healthcare US, LLC.)

  FDA approved the original ANDA for roflumilast by Solco Healthcare US, LLC, authorizing a generic version of the COPD medication.

• FDA approval · 2022-01-12
  FDA Approved: AZITHROMYCIN — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for AZITHROMYCIN submitted by Aurobindo Pharma Limited under an ANDA.

• FDA approval · 2020-03-09
  FDA Approved: CEFDINIR — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for CEFDINIR (cefdinir) from Aurobindo Pharma Limited, a generic cephalosporin antibiotic.

• FDA approval · 2020-01-23
  FDA Approved: AZITHROMYCIN — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for azithromycin filed by Aurobindo Pharma Limited.

• FDA approval · 2019-12-19
  FDA Approved: CEFUROXIME AXETIL — Supplemental Application (Golden State Medical Supply, Inc.)

  FDA approved a supplemental application for cefuroxime axetil from Golden State Medical Supply, Inc., recognizing an update to this generic …

• FDA approval · 2018-10-03
  FDA Approved: ROFLUMILAST — Original Application (Jubilant Cadista Pharmaceuticals Inc.)

  FDA approved Jubilant Cadista's original application for roflumilast, a PDE-4 inhibitor, to reduce the risk of COPD exacerbations in adults …

• FDA approval · 2018-03-05
  FDA Approved: MUCUS DM — Original Application (HyVee Inc)

  FDA approved HyVee Inc's MUCUS DM as an original-application generic product containing dextromethorphan hydrobromide and guaifenesin for te…

• FDA approval · 2017-12-29
  FDA Approved: GUAIFENESIN AND PSEUDOEPHEDRINE HCL — Original Application (Dr. Reddys Laboratories Limited)

  FDA approved an original ANDA for guaifenesin and pseudoephedrine hydrochloride tablets from Dr. Reddys Laboratories Limited, establishing a…

• FDA approval · 2017-07-13
  FDA Approved: MUCINEX DM MAXIMUM STRENGTH — Supplemental Application (RB Health (US) LLC)

  FDA approved a supplemental application for Mucinex DM Maximum Strength (guaifenesin and dextromethorphan hydrobromide) by RB Health (US) LL…

• FDA approval · 2016-06-09
  FDA Approved: COMBIVENT RESPIMAT — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Combivent Respimat (ipratropium bromide and albuterol) from Boehringer Ingelheim Pharmaceuticals…

• FDA approval · 2016-01-10
  FDA Approved: ACETYLCYSTEINE — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for Acetylcysteine from Fresenius Kabi USA, LLC, under an ANDA.

• FDA approval · 2015-11-24
  FDA Approved: DALIRESP — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approves a supplemental application for Daliresp (roflumilast) submitted by AstraZeneca.

• FDA approval · 2015-09-28
  FDA Approved: CLARITHROMYCIN — Original Application (Solaris Pharma Corporation)

  FDA approved an Original Application (ANDA) for Clarithromycin from Solaris Pharma Corporation, establishing a generic version of clarithrom…