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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 210045
Company: PURPLE BIOTECH

Medication Guide

Products on NDA 210045

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CONSENSI	AMLODIPINE BESYLATE; CELECOXIB	EQ 2.5MG BASE;200MG	TABLET;ORAL	Discontinued	None	Yes	No
CONSENSI	AMLODIPINE BESYLATE; CELECOXIB	EQ 5MG BASE;200MG	TABLET;ORAL	Discontinued	None	Yes	No
CONSENSI	AMLODIPINE BESYLATE; CELECOXIB	EQ 10MG BASE;200MG	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 210045

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/31/2018	ORIG-1	Approval	Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210045s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210045Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210045Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/28/2021	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210045s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210045Orig1s009ltr.pdf
05/12/2020	SUPPL-6	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210045s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210045Orig1s006ltr.pdf

Labels for NDA 210045

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/28/2021	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210045s009lbl.pdf
05/12/2020	SUPPL-6	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210045s006lbl.pdf
05/12/2020	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210045s006lbl.pdf
05/31/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210045s000lbl.pdf

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