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FDA Approval

Perindopril Erbumine

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

FDA Approval Summary

Company
Effective Date
May 28, 2015
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Perindopril(4 mg in 1 1)

Products2

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

Perindopril Erbumine

Product Details

NDC Product Code
10135-599
Application Number
NDA020184
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
June 4, 2015
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
LACTOSEInactive
Code: J2B2A4N98GClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
Code: 1964X464OJClass: ACTIBQuantity: 4 mg in 1 1
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT

Perindopril Erbumine

Product Details

NDC Product Code
10135-600
Application Number
NDA020184
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
June 4, 2015
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
LACTOSEInactive
Code: J2B2A4N98GClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
Code: 1964X464OJClass: ACTIBQuantity: 8 mg in 1 1
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
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