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Trihexyphenidyl Hydrochloride

Trihexyphenidyl Hydrochloride Oral Solution, USP 2 mg per 5 mL

Approved
Approval ID

294cd88d-d9e8-4938-b4be-c3adc4a35de0

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 21, 2022

Manufacturers
FDA

Akorn

DUNS: 117693100

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 Code61748-054
Application NumberANDA040251
Product Classification
M
Marketing Category
C73584
G
Generic Name
Trihexyphenidyl Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 21, 2022
FDA Product Classification

INGREDIENTS (8)

TRIHEXYPHENIDYL HYDROCHLORIDEActive
Quantity: 2 mg in 5 mL
Code: AO61G82577
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PEPPERMINTInactive
Code: V95R5KMY2B
Classification: IACT

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Trihexyphenidyl Hydrochloride - FDA Drug Approval Details