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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
January 1, 2010
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Perindopril(4 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Lupin Limited

Lupin Pharmaceuticals, Inc

677600414

Products3

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
68180-236
Application Number
ANDA078263
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
February 26, 2010
Code: 1964X464OJClass: ACTIBQuantity: 4 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT

Perindopril Erbumine

Product Details

NDC Product Code
68180-235
Application Number
ANDA078263
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
February 26, 2010
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
Code: 1964X464OJClass: ACTIBQuantity: 2 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT

Perindopril Erbumine

Product Details

NDC Product Code
68180-237
Application Number
ANDA078263
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
February 26, 2010
Code: 1964X464OJClass: ACTIBQuantity: 8 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
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