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FDA Approval

Marplan

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
July 17, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Isocarboxazid(10 mg in 1 1)

Products1

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

Marplan

Product Details

NDC Product Code
30698-032
Application Number
NDA011961
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
July 17, 2023
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
D&C RED NO. 27Inactive
Code: 2LRS185U6KClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
Code: 34237V843TClass: ACTIBQuantity: 10 mg in 1 1
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98GClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
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