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Trihexyphenidyl Hydrochloride

Trihexyphenidyl Hydrochloride Oral Solution USP 2 mg per 5 mL

Approved
Approval ID

9036c9f0-6d2d-4d0f-a20e-e36f9be228f7

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 2, 2023

Manufacturers
FDA

PAI Holdings, LLC

DUNS: 044940096

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Trihexyphenidyl Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0121-0658
Application NumberANDA040177
Product Classification
M
Marketing Category
C73584
G
Generic Name
Trihexyphenidyl Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 2, 2023
FDA Product Classification

INGREDIENTS (8)

TRIHEXYPHENIDYL HYDROCHLORIDEActive
Quantity: 2 mg in 5 mL
Code: AO61G82577
Classification: ACTIB
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
SORBITOL SOLUTIONInactive
Code: 8KW3E207O2
Classification: IACT

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Trihexyphenidyl Hydrochloride - FDA Drug Approval Details