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DESMOPRESSIN ACETATE

These highlights do not include all the information needed to use DESMOPRESSIN ACETATE INJECTION USP safely and effectively. See full prescribing information for DESMOPRESSIN ACETATE INJECTION USP. DESMOPRESSIN ACETATE injection, for intravenous or subcutaneous use Initial U.S. Approval: 1978

Approved
Approval ID

b2fad59d-6176-4e09-9fbb-5cdd7f8f1568

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 16, 2023

Manufacturers
FDA

UBI Pharma Inc.

DUNS: 658871159

Products 1

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

DESMOPRESSIN ACETATE

PRODUCT DETAILS

NDC Product Code72843-459
Application NumberANDA210218
Marketing CategoryC73584
Route of AdministrationSUBCUTANEOUS, INTRAVENOUS
Effective DateOctober 16, 2023
Generic NameDESMOPRESSIN ACETATE

INGREDIENTS (1)

DESMOPRESSIN ACETATEActive
Quantity: 4 ug in 1 mL
Code: XB13HYU18U
Classification: ACTIB

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DESMOPRESSIN ACETATE - FDA Drug Approval Details