Last Updated: May 11, 2026

Details for New Drug Application (NDA): 218854


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NDA 218854 describes PSEUDOEPHEDRINE HYDROCHLORIDE, which is a drug marketed by Aurobindo Pharma, Aurobindo Pharma Ltd, L Perrigo Co, Sun Pharm Inds Ltd, Cent Pharms, Graham Dm, Kv Pharm, and Sandoz, and is included in nine NDAs. It is available from thirty-three suppliers. Additional details are available on the PSEUDOEPHEDRINE HYDROCHLORIDE profile page.

The generic ingredient in PSEUDOEPHEDRINE HYDROCHLORIDE is pseudoephedrine hydrochloride; triprolidine hydrochloride. There are forty-nine drug master file entries for this compound. Additional details are available on the pseudoephedrine hydrochloride; triprolidine hydrochloride profile page.
Summary for 218854
Tradename:PSEUDOEPHEDRINE HYDROCHLORIDE
Applicant:Aurobindo Pharma Ltd
Ingredient:pseudoephedrine hydrochloride
Patents:0
Pharmacology for NDA: 218854
Mechanism of ActionAdrenergic alpha-Agonists
Suppliers and Packaging for NDA: 218854
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PSEUDOEPHEDRINE HYDROCHLORIDE pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 218854 ANDA WALGREEN CO. 0363-6611 0363-6611-10 1 BLISTER PACK in 1 CARTON (0363-6611-10) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
PSEUDOEPHEDRINE HYDROCHLORIDE pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 218854 ANDA Aurohealth LLC 58602-884 58602-884-27 1 BLISTER PACK in 1 CARTON (58602-884-27) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength240MG
Approval Date:Dec 29, 2025TE:RLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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