Marplan
Marplan
Approved
Approval ID
ac387aa0-3f04-4865-a913-db6ed6f4fdc5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 17, 2023
Manufacturers
FDA
Validus Pharmaceuticals LLC
DUNS: 801194619
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
isocarboxazid
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code30698-032
Application NumberNDA011961
Product Classification
M
Marketing Category
C73594
G
Generic Name
isocarboxazid
Product Specifications
Route of AdministrationORAL
Effective DateJuly 17, 2023
FDA Product Classification
INGREDIENTS (7)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
D&C RED NO. 27Inactive
Code: 2LRS185U6K
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
ISOCARBOXAZIDActive
Quantity: 10 mg in 1 1
Code: 34237V843T
Classification: ACTIB
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT