Common Cold

• FDA approval · 2025-12-29
  FDA Approved: PSEUDOEPHEDRINE HYDROCHLORIDE — Original Application (WALGREEN CO.)

  FDA approved Walgreens' original application for pseudoephedrine hydrochloride as a generic drug, enabling market authorization for this dec…

• FDA approval · 2025-05-20
  FDA Approved: CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for Sun Pharmaceutical Industries' Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride, updat…

• 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 · 2025-01-27
  FDA Approved: IPRATROPIUM BROMIDE — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approves Lupin Pharmaceuticals' original application for ipratropium bromide, a generic formulation of the anticholinergic bronchodilato…

• FDA approval · 2024-05-14
  FDA Approved: ALLERGY RELIEF-D — Original Application (HEB)

  FDA approves ALLERGY RELIEF-D, a combination product of loratadine and pseudoephedrine sulfate, under an original application by HEB, for re…

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• FDA approval · 2024-03-20
  FDA Approved: DIPHENHYDRAMINE HYDROCHLORIDE — Original Application (Sagent Pharmaceuticals)

  FDA approved a generic diphenhydramine hydrochloride product through an Original Application (ANDA 218448) by Sagent Pharmaceuticals.

• FDA approval · 2023-12-15
  FDA Approved: TUXARIN — Supplemental Application (Mainpointe Pharmaceuticals)

  FDA approved a supplemental application for TUXARIN (codeine phosphate and chlorpheniramine maleate) submitted by Mainpointe Pharmaceuticals…

• FDA approval · 2023-11-09
  FDA Approved: CLARITIN-D 12 HOUR — Supplemental Application (Bayer HealthCare LLC.)

  FDA approved a supplemental application for Claritin-D 12 Hour (loratadine and pseudoephedrine sulfate) from Bayer HealthCare LLC. This acti…

• FDA approval · 2023-05-08
  FDA Approved: BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)

  FDA approved a supplemental application for the cough/cold combination of brompheniramine maleate, pseudoephedrine hydrochloride, and dextro…

• FDA approval · 2023-02-28
  FDA Approved: PHENYLEPHRINE HYDROCHLORIDE — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved a generic version of phenylephrine hydrochloride through an Original Application (ANDA 209968) by Heritage Pharmaceuticals (d/b…

• FDA approval · 2022-10-27
  FDA Approved: BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE — Supplemental Application (Acella Pharmaceuticals, LLC)

  The FDA granted supplemental approval for Acella Pharmaceuticals' generic combination product containing brompheniramine maleate, pseudoephe…

• FDA approval · 2022-09-29
  FDA Approved: PHENYLEPHRINE HYDROCHLORIDE — Original Application (NorthStar RxLLC)

  FDA approved phenylephrine hydrochloride under an original application for temporary relief of nasal congestion due to the common cold, hay …

• FDA approval · 2022-08-30
  FDA Approved: PHENYLEPHRINE HYDROCHLORIDE — Original Application (Lifestar Pharma LLC)

  FDA approves Lifestar Pharma LLC's phenylephrine hydrochloride under an Original Application (ANDA). This approval introduces a generic phen…

• FDA approval · 2022-08-22
  FDA Approved: GUAIFENESIN AND PSEUDOEPHEDRINE HCL — Original Application (Granules India Ltd)

  FDA approved Granules India Ltd's guaifenesin and pseudoephedrine HCl as an Original Application (ANDA) for a generic combination product.

• FDA approval · 2022-06-01
  FDA Approved: NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE COLD AND SINUS — Original Application (VESPYR BRANDS LLC)

  FDA approved Naproxen Sodium and Pseudoephedrine Hydrochloride Cold and Sinus as an Original Application for a new combination OTC product t…

• FDA approval · 2021-11-23
  FDA Approved: ADVIL ALLERGY SINUS — Supplemental Application (Haleon US Holdings LLC)

  FDA approved a supplemental application for Advil Allergy Sinus, a combination product containing chlorpheniramine maleate, ibuprofen, and p…

• FDA approval · 2021-11-19
  FDA Approved: ADVIL COLD AND SINUS — Supplemental Application (Haleon US Holdings LLC)

  FDA approved a supplemental application for Advil Cold and Sinus, a combination of ibuprofen and pseudoephedrine hydrochloride, from Haleon …

• FDA approval · 2021-11-19
  FDA Approved: ADVIL COLD AND SINUS — Supplemental Application (Haleon US Holdings LLC)

  The FDA approved a supplemental application for Advil Cold and Sinus (ibuprofen and pseudoephedrine hydrochloride) from Haleon US Holdings L…

• FDA approval · 2021-11-03
  FDA Approved: ZYRTEC-D — Supplemental Application (Kenvue Brands LLC)

  FDA approved a supplemental application for ZYRTEC-D (cetirizine hydrochloride and pseudoephedrine hydrochloride) from Kenvue Brands LLC, au…

• 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 · 2020-07-14
  FDA Approved: BROMPHENIRAMINE, PSEUDOEPHEDRINE, DEXTROMETHORPHAN — Original Application (Ascend Laboratories, LLC)

  FDA approves the original ANDA for a triple-ingredient cough/cold product containing brompheniramine, pseudoephedrine, and dextromethorphan …

• FDA approval · 2020-06-16
  FDA Approved: BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, — Original Application (Eywa Pharma Inc)

  FDA approved Eywa Pharma Inc for the original application of a generic brompheniramine maleate and pseudoephedrine hydrochloride combination…

• FDA approval · 2020-04-17
  FDA Approved: BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE — Original Application (Chartwell Governmental & Specialty RX, LLC)

  FDA approved the original application for a generic combination cough/cold medicine containing brompheniramine maleate, pseudoephedrine hydr…

• FDA approval · 2019-09-06
  FDA Approved: ADVIL ALLERGY AND CONGESTION RELIEF — Supplemental Application (Haleon US Holdings LLC)

  FDA approved a supplemental application for ADVIL ALLERGY AND CONGESTION RELIEF to update its labeling. The product combines chlorpheniramin…

• FDA approval · 2019-01-31
  FDA Approved: PHENYLEPHRINE HYDROCHLORIDE — Original Application (Sandoz Inc)

  FDA approved an Original Application for Phenylephrine Hydrochloride from Sandoz Inc, enabling the marketing of this generic product.