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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 040177


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NDA 040177 describes TRIHEXYPHENIDYL HYDROCHLORIDE, which is a drug marketed by Chartwell Rx, Pharm Assoc, Pharm Ventures, Hikma, Natco Pharma Ltd, Novitium Pharma, Nylos, Vangard, and Watson Labs, and is included in thirteen NDAs. It is available from eight suppliers. Additional details are available on the TRIHEXYPHENIDYL HYDROCHLORIDE profile page.

The generic ingredient in TRIHEXYPHENIDYL HYDROCHLORIDE is trihexyphenidyl hydrochloride. There are three drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the trihexyphenidyl hydrochloride profile page.
Summary for 040177
Tradename:TRIHEXYPHENIDYL HYDROCHLORIDE
Applicant:Pharm Assoc
Ingredient:trihexyphenidyl hydrochloride
Patents:0
Medical Subject Heading (MeSH) Categories for 040177
Antiparkinson Agents
Muscarinic Antagonists
Suppliers and Packaging for NDA: 040177
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRIHEXYPHENIDYL HYDROCHLORIDE trihexyphenidyl hydrochloride ELIXIR;ORAL 040177 ANDA PAI Holdings, LLC dba PAI Pharma 0121-0658 0121-0658-16 473 mL in 1 BOTTLE (0121-0658-16)
TRIHEXYPHENIDYL HYDROCHLORIDE trihexyphenidyl hydrochloride ELIXIR;ORAL 040177 ANDA REMEDYREPACK INC. 70518-3268 70518-3268-0 10 CUP, UNIT-DOSE in 1 BOX (70518-3268-0) / 12.5 mL in 1 CUP, UNIT-DOSE (70518-3268-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:ELIXIR;ORALStrength2MG/5ML
Approval Date:Apr 17, 1997TE:AARLD:No

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Preferred Citation:

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