Nasal Congestion

• FDA approval · 2026-04-03
  FDA Approved: PHENYLEPHRINE HYDROCHLORIDE — Original Application (Baxter Healthcare Corporation)

  FDA approved Baxter Healthcare Corporation's phenylephrine hydrochloride as an original ANDA, confirming a generic version of this decongest…

• 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 · 2024-03-14
  FDA Approved: PHENYLEPHRINE HYDROCHLORIDE — Original Application (Method Pharmaceuticals, LLC)

  FDA approved an Original Application for Phenylephrine hydrochloride from Method Pharmaceuticals, LLC.

• 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 · 2022-09-29
  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 …

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• 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 · 2020-11-13
  FDA Approved: PHENYLEPHRINE HYDROCHLORIDE — Original Application (Eugia US LLC)

  FDA approved the original application for Phenylephrine Hydrochloride from Eugia US LLC (a generic drug product).

• FDA approval · 2020-06-11
  FDA Approved: PHENYLEPHRINE HYDROCHLORIDE — Original Application (Armas Pharmaceuticals Inc.)

  FDA approves an original application for phenylephrine hydrochloride from Armas Pharmaceuticals Inc. as a generic drug.

• FDA approval · 2020-06-05
  FDA Approved: PHENYLEPHRINE HYDROCHLORIDE — Original Application (Gland Pharma Limited)

  FDA approved the original application for phenylephrine hydrochloride from Gland Pharma Limited as a generic product. This approval enables …

• FDA approval · 2019-06-19
  FDA Approved: PHENYLEPHRINE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for Phenylephrine Hydrochloride from Hikma Pharmaceuticals USA, authorizing changes to labeling …

• 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.

• FDA approval · 2019-01-29
  FDA Approved: PHENYLEPHRINE HYDROCHLORIDE — Original Application (Fresenius Kabi USA, LLC)

  FDA approved Fresenius Kabi USA, LLC's Original Application for phenylephrine hydrochloride as a generic drug product.

• FDA approval · 2018-04-27
  FDA Approved: PHENYLEPHRINE HYDROCHLORIDE — Original Application (Meitheal Pharmaceuticals Inc.)

  FDA approved Meitheal Pharmaceuticals' phenylephrine hydrochloride product under an Original Application (ANDA 210333).

• FDA approval · 2016-01-26
  FDA Approved: FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI — Supplemental Application (Dr. Reddy's Laboratories Inc.)

  FDA approved a supplemental application for a fixed-dose combination of fexofenadine HCl and pseudoephedrine HCl to treat allergy symptoms w…

• FDA approval · 2014-02-12
  FDA Approved: ZYRTEC-D — Supplemental Application (Kenvue Brands LLC)

  The FDA approved a supplemental application for ZYRTEC-D, filed by Kenvue Brands LLC. ZYRTEC-D combines cetirizine hydrochloride and pseudoe…