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desmopressin acetate

Desmopressin Acetate Injection, USP, 4 mcg/mL

Approved
Approval ID

2dc2cec8-6953-4a33-9356-11534fba1fb8

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 23, 2020

Manufacturers
FDA

Sun Pharmaceutical Industries, Inc.

DUNS: 146974886

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 Code62756-529
Application NumberANDA091280
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateJanuary 23, 2020
Generic Namedesmopressin acetate

INGREDIENTS (5)

SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
DESMOPRESSIN ACETATEActive
Quantity: 4 ug in 1 mL
Code: XB13HYU18U
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
CHLOROBUTANOL HEMIHYDRATEInactive
Code: 3X4P6271OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

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desmopressin acetate - FDA Drug Approval Details