Pseudoephedrine Hydrochloride

Sold as Novafed, Sudafed 12 Hour, Sudafed 24 Hour. Every FDA application for this active ingredient: 3 branded and 5 generic.

As of Nov 15, 2026, FDA lists 8 applications for Pseudoephedrine Hydrochloride (sold as Novafed, Sudafed 12 Hour, Sudafed 24 Hour), first approved Aug 29, 1975, with 0 new uses approved and 0 published complete response letters.

First approved: Aug 29, 1975
Applications: 8
New uses approved: 0
Complete response letters: 0

Clinical Trials

4 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Efficacy of Buteyko Breathing in Seniors With Chronic Eustachian Tube DysfunctionEustachian Tube Dysfunction · Cairo University	Not applicable	Recruiting	Sep 25, 2025
Nasal Decongestant to Reduce Perioperative Adverse Events in Children With Upper Respiratory Track Infections Having Anesthesia.Perioperative Respiratory Adverse Events, Anesthesia Outcomes · Telethon Kids Institute	Phase 4	Recruiting	Jun 3, 2025
Study of Complication Rates in Cataract Surgery Patients Treated With Combined Pre-operative NSAID, OMIDRIA, and Subconjunctival Triamcinolone Acetonide Compared With Peri-operative SOCCataract · Inder Paul Singh, M.D.	Phase 1 / Phase 2	Recruiting	Nov 8, 2024
Appropriate Dosage of Vasopressor in Neonates and InfantsHypotension, Neonatal Hypotension · Seoul National University Hospital	Phase 4	Not yet recruiting	Feb 13, 2024

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Aug 29, 1975	NovafedNDA 17603 · New dosage form	Sanofi Aventis US	26	Discontinued
Oct 31, 1991	Sudafed 12 HourANDA 73585	Mcneil Cons	13	Discontinued
Dec 15, 1992	Sudafed 24 HourNDA 20021 · New dosage form	Kenvue Brands	8	Discontinued
Feb 26, 1999	Pseudoephedrine HydrochlorideANDA 75153	L Perrigo Co	10	Marketed
Sep 28, 2005	Pseudoephedrine HydrochlorideANDA 77442	Sun Pharm Inds Ltd	0	Marketed
Jun 9, 2017	Pseudoephedrine HydrochlorideANDA 209008	Aurobindo Pharma	0	Marketed
Dec 29, 2025	Pseudoephedrine HydrochlorideANDA 218854	Aurobindo Pharma Ltd	0	Marketed
—	Sudafed 12 HourNDA 17941	Glaxosmithkline	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA