Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 219531
Company: BRILLIAN PHARMA

Products on NDA 219531

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SDAMLO	AMLODIPINE BESYLATE	EQ 2.5MG BASE/BOT	FOR SOLUTION;ORAL	Prescription	None	Yes	Yes
SDAMLO	AMLODIPINE BESYLATE	EQ 5MG BASE/BOT	FOR SOLUTION;ORAL	Prescription	None	Yes	Yes
SDAMLO	AMLODIPINE BESYLATE	EQ 10MG BASE/BOT	FOR SOLUTION;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 219531

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/24/2025	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219531s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/219531Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/219531Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/08/2026	SUPPL-2	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/219531Orig1s002ltr.pdf

Labels for NDA 219531

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/24/2025	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219531s000lbl.pdf