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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 219423
Company: AZURITY

Products on NDA 219423

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
WIDAPLIK	AMLODIPINE BESYLATE; INDAPAMIDE; TELMISARTAN	EQ 1.25MG BASE;0.625MG;10MG	TABLET;ORAL	Discontinued	None	Yes	No
WIDAPLIK	AMLODIPINE BESYLATE; INDAPAMIDE; TELMISARTAN	EQ 2.5MG BASE;1.25MG;20MG	TABLET;ORAL	Discontinued	None	Yes	No
WIDAPLIK	AMLODIPINE BESYLATE; INDAPAMIDE; TELMISARTAN	EQ 5MG BASE;2.5MG;40MG	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 219423

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/05/2025	ORIG-1	Approval	Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219423s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/219423Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2026/219423Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/28/2026	SUPPL-2	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/219423Orig1s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/219423Orig1s002ltr.pdf

Labels for NDA 219423

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/28/2026	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/219423Orig1s002lbl.pdf
05/28/2026	SUPPL-2	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/219423Orig1s002lbl.pdf
06/05/2025	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219423s000lbl.pdf

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