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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

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Marplan - FDA Drug Approval Details