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Dichlorphenamide

These highlights do not include all the information needed to use DICHLORPHENAMIDE TABLETS safely and effectively. See full prescribing information for DICHLORPHENAMIDE TABLETS. DICHLORPHENAMIDE tablets, for oral use Initial U.S. Approval: 1958

Approved
Approval ID

fa142844-6775-4661-acc2-9ac44f3b6613

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 10, 2023

Manufacturers
FDA

Xeris Pharmaceuticals, Inc.

DUNS: 609377135

Products 1

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

Dichlorphenamide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72065-002
Application NumberNDA011366
Product Classification
M
Marketing Category
C73605
G
Generic Name
Dichlorphenamide
Product Specifications
Route of AdministrationORAL
Effective DateMarch 9, 2023
FDA Product Classification

INGREDIENTS (4)

LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
DICHLORPHENAMIDEActive
Quantity: 50 mg in 1 1
Code: VVJ6673MHY
Classification: ACTIB

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Dichlorphenamide - FDA Drug Approval Details