Upper Respiratory Tract Infection

• 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 · 2020-09-30
  FDA Approved: BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE — Original Application (BIONPHARMA INC.)

  FDA approved Bionpharma's original ANDA for a three-drug cough/cold product containing brompheniramine maleate, pseudoephedrine hydrochlorid…

• FDA approval · 2018-11-01
  FDA Approved: MUCUS RELIEF DM — Original Application (Dolgencorp, Inc. (DOLLAR GENERAL & REXALL))

  FDA approved the original application for MUCUS RELIEF DM, a combination cough suppressant and expectorant (guaifenesin and dextromethorphan…

• FDA approval · 2018-06-08
  FDA Approved: PROMETHAZINE AND PHENYLEPHRINE HCL, AND CODEINE PHOSPHATE — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for PROMETHAZINE AND PHENYLEPHRINE HCL, AND CODEINE PHOSPHATE by Amneal Pharmaceuticals LLC.

• 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…

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• 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 · 2017-03-17
  FDA Approved: MUCUS RELIEF DM MAXIMUM STRENGTH — Original Application (Better Living Brands LLC)

  The FDA approved the original ANDA for MUCUS RELIEF DM MAXIMUM STRENGTH, a combination product of guaifenesin and dextromethorphan hydrobrom…

• FDA approval · 2016-08-25
  FDA Approved: TUXARIN — Supplemental Application (Mainpointe Pharmaceuticals)

  FDA approved a supplemental application for TUXARIN (codeine phosphate and chlorpheniramine maleate) from Mainpointe Pharmaceuticals. The ap…

• FDA approval · 2014-07-15
  FDA Approved: BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE — Original Application (Padagis US LLC)

  FDA approved an Original Application (ANDA) for a triple-ingredient cough/cold relief product containing brompheniramine maleate, pseudoephe…

• FDA approval · 2014-07-03
  FDA Approved: EQUALINE CONGESTION RELIEF — Original Application (United Natural Foods, Inc. dba UNFI)

  FDA approved Equaline Congestion Relief, a generic combination of ibuprofen and phenylephrine hydrochloride. It is intended for temporary re…

• FDA approval · 2013-08-02
  FDA Approved: GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE — Supplemental Application (WALGREEN COMPANY)

  FDA approved Walgreens' supplemental application for Guaifenesin and Pseudoephedrine Hydrochloride, resulting in changes to the product labe…

• FDA approval · 2006-09-27
  FDA Approved: IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE — Supplemental Application (Rite-Aid)

  FDA approved a supplemental application for Rite Aid's ibuprofen and pseudoephedrine hydrochloride product, indicating an approval modificat…

• FDA approval · 2006-08-23
  FDA Approved: MUCINEX — Supplemental Application (RB Health (US) LLC)

  FDA approved a supplemental application for Mucinex (guaifenesin) from RB Health (US) LLC, indicating FDA action on a supplemental submissio…