Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 212895
Company: CSPC OUYI

Products on NDA 212895

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CONJUPRI	LEVAMLODIPINE MALEATE	EQ 1.25MG BASE	TABLET;ORAL	Discontinued	None	Yes	No
CONJUPRI	LEVAMLODIPINE MALEATE	EQ 2.5MG BASE	TABLET;ORAL	Prescription	None	Yes	No
CONJUPRI	LEVAMLODIPINE MALEATE	EQ 5MG BASE	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 212895

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/19/2019	ORIG-1	Approval	Type 2 - New Active Ingredient and Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212895s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/212895Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212895Orig1s000TOC.cfm

Labels for NDA 212895

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/19/2019	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212895s000lbl.pdf