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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 075153


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NDA 075153 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 075153
Tradename:PSEUDOEPHEDRINE HYDROCHLORIDE
Applicant:L Perrigo Co
Ingredient:pseudoephedrine hydrochloride
Patents:0
Pharmacology for NDA: 075153
Mechanism of ActionAdrenergic alpha-Agonists
Suppliers and Packaging for NDA: 075153
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PSEUDOEPHEDRINE HYDROCHLORIDE pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 075153 ANDA L. Perrigo Company 0113-0054 0113-0054-52 10 BLISTER PACK in 1 CARTON (0113-0054-52) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
PSEUDOEPHEDRINE HYDROCHLORIDE pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 075153 ANDA L. Perrigo Company 0113-2017 0113-2017-60 20 BLISTER PACK in 1 CARTON (0113-2017-60) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength120MG
Approval Date:Feb 26, 1999TE:RLD:No

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Preferred Citation:

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