Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 211340
Company: AZURITY

Products on NDA 211340

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
KATERZIA	AMLODIPINE BENZOATE	EQ 1MG BASE/ML	SUSPENSION;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 211340

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/08/2019	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211340s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211340Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211340Orig1s000TOC.cfm

Labels for NDA 211340

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/08/2019	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211340s000lbl.pdf

Therapeutic Equivalents for NDA 211340

KATERZIA

SUSPENSION;ORAL; EQ 1MG BASE/ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
KATERZIA	AMLODIPINE BENZOATE	EQ 1MG BASE/ML	SUSPENSION;ORAL	Prescription	Yes	AB	211340	AZURITY