Desmopressin Acetate
Desmporessin Acetate Tablets 0.1 mg, 0.2 mg
Approved
Approval ID
72aeef35-c102-b628-0219-9822651887eb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 31, 2023
Manufacturers
FDA
Apotex Corp.
DUNS: 845263701
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
desmopressin acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60505-0258
Application NumberANDA077414
Product Classification
M
Marketing Category
C73584
G
Generic Name
desmopressin acetate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 31, 2023
FDA Product Classification
INGREDIENTS (4)
DESMOPRESSIN ACETATEActive
Quantity: 0.2 mg in 1 1
Code: XB13HYU18U
Classification: ACTIB
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
desmopressin acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60505-0257
Application NumberANDA077414
Product Classification
M
Marketing Category
C73584
G
Generic Name
desmopressin acetate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 31, 2023
FDA Product Classification
INGREDIENTS (4)
DESMOPRESSIN ACETATEActive
Quantity: 0.1 mg in 1 1
Code: XB13HYU18U
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT