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FDA NDA · NDA219531

SDAMLO

amlodipine

Sponsor: BRILLIAN PHARMA

APPLICATION
NDA219531
TYPE
NDA
ORIGINAL APPROVAL
2025-07-24
LATEST ACTION
2026-05-08
ROUTE
ORAL
DOSAGE FORM
FOR SOLUTION
MARKETING STATUS
Prescription

Products

SDAMLO · ReferencePrescription
AMLODIPINE BESYLATE EQ 10MG BASE/BOT · FOR SOLUTION · ORAL
SDAMLO · ReferencePrescription
AMLODIPINE BESYLATE EQ 2.5MG BASE/BOT · FOR SOLUTION · ORAL
SDAMLO · ReferencePrescription
AMLODIPINE BESYLATE EQ 5MG BASE/BOT · FOR SOLUTION · ORAL

Approval history

2026-05-08Labeling · Supplement 2 · standard — Letter ↗AP
2025-07-24Type 3 - New Dosage Form · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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