MedPath

Depen

DEPEN® (penicillamine tablets, USP) Titratable Tablets

Approved
Approval ID

38f8ae60-b354-11de-8a39-0800200c9a66

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 19, 2023

Manufacturers
FDA

Meda Pharmaceuticals Inc.

DUNS: 051229602

Products 1

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

Penicillamine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0037-4401
Application NumberNDA019854
Product Classification
M
Marketing Category
C73594
G
Generic Name
Penicillamine
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 17, 2019
FDA Product Classification

INGREDIENTS (1)

PENICILLAMINEActive
Quantity: 250 mg in 1 1
Code: GNN1DV99GX
Classification: ACTIB

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Depen - FDA Drug Approval Details