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FDA Approval

NORLIQVA

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

FDA Approval Summary

Company
CMP Pharma, Inc.
DUNS: 005224175
Effective Date
February 28, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Amlodipine(1 mg in 1 mL)

Products1

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

NORLIQVA

Product Details

NDC Product Code
46287-035
Application Number
NDA214439
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
February 28, 2022
glycerinInactive
Code: PDC6A3C0OXClass: IACT
Code: 1J444QC288Class: ACTIBQuantity: 1 mg in 1 mL
maltitolInactive
Code: D65DG142WKClass: IACT
alcoholInactive
Code: 3K9958V90MClass: IACT
butylated hydroxyanisoleInactive
Code: REK4960K2UClass: IACT
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