Sinusitis

• EMA approval · 2026-06-25
  EMA Authorised: Tezspire (tezepelumab) — AstraZeneca AB

  The EMA has authorised Tezspire (tezepelumab) by AstraZeneca AB for therapeutic use in asthma and sinusitis.

• 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…

• EMA approval · 2025-10-22
  EMA Authorised: Tezspire (tezepelumab) — AstraZeneca AB

  The European Medicines Agency authorised Tezspire (tezepelumab) by AstraZeneca AB for the treatment of asthma and sinusitis in the EU.

• 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 · 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.

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• 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 · 2024-04-25
  FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Supplemental Application (NorthStar Rx LLC)

  FDA approved a Supplemental Application for Amoxicillin and clavulanate potassium by NorthStar Rx LLC, indicating a modification to an exist…

• FDA approval · 2023-10-31
  FDA Approved: AMPICILLIN — Original Application (Aurobindo Pharma Limited)

  FDA approved an original application for Ampicillin from Aurobindo Pharma Limited, granting marketing authorization for a generic ampicillin…

• 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 · 2022-09-29
  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 · 2022-06-01
  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 · 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 · 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 · 2021-02-19
  FDA Approved: CEFDINIR — Original Application (American Health Packaging)

  FDA approves the original ANDA for cefdinir (CEFDINIR) by American Health Packaging, making a generic cefdinir product available.

• FDA approval · 2020-07-30
  FDA Approved: ADVIL SINUS CONGESTION AND PAIN — Supplemental Application (Haleon US Holdings LLC)

  FDA approved a supplemental application for Advil Sinus Congestion and Pain (ibuprofen and phenylephrine hydrochloride) from Haleon US Holdi…

• FDA approval · 2020-05-01
  FDA Approved: AZITHROMYCIN DIHYDRATE — Supplemental Application (Precision Dose, Inc.)

  FDA approved a supplemental application for azithromycin dihydrate submitted by Precision Dose, Inc.

• 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 · 2020-02-11
  FDA Approved: CEFDINIR — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for CEFDINIR (cefdinir) submitted by Sandoz Inc.

• 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 · 2019-07-09
  FDA Approved: ADVIL SINUS CONGESTION AND PAIN — Supplemental Application (Haleon US Holdings LLC)

  FDA approves a supplemental application for Advil Sinus Congestion and Pain (ibuprofen and phenylephrine HCl) from Haleon US Holdings LLC.

• 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 · 2017-12-01
  FDA Approved: IBUPROFEN AND PSEUDOEPHEDRINE HCL — Original Application (Aurohealth LLC)

  FDA approved Aurohealth LLC's ibuprofen and pseudoephedrine HCl combination as an Original Application. It is an over-the-counter product in…

• FDA approval · 2017-06-09
  FDA Approved: PSEUDOEPHEDRINE HCL — Original Application (Better Living Brands LLC)

  FDA approved the original ANDA for pseudoephedrine HCl (Better Living Brands LLC), authorizing its marketing as an over-the-counter nasal de…