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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 077442


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NDA 077442 describes PSEUDOEPHEDRINE HYDROCHLORIDE, which is a drug marketed by Aurobindo Pharma, L Perrigo Co, Sun Pharm Inds Ltd, Cent Pharms, Graham Dm, Kv Pharm, and Sandoz, and is included in eight NDAs. It is available from thirty-one 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 077442
Tradename:PSEUDOEPHEDRINE HYDROCHLORIDE
Applicant:Sun Pharm Inds Ltd
Ingredient:pseudoephedrine hydrochloride
Patents:0
Pharmacology for NDA: 077442
Mechanism of ActionAdrenergic alpha-Agonists
Suppliers and Packaging for NDA: 077442
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PSEUDOEPHEDRINE HYDROCHLORIDE pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 077442 ANDA Walgreen Company 0363-0204 0363-0204-20 20 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (0363-0204-20)
PSEUDOEPHEDRINE HYDROCHLORIDE pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 077442 ANDA Walgreen Company 0363-0204 0363-0204-69 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (0363-0204-69)

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength120MG
Approval Date:Sep 28, 2005TE:RLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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