Consensi

NDA 210045, held by Purple Biotech. Amlodipine Besylate; Celecoxib.

As of Nov 14, 2026, NDA 210045 (Consensi), held by Purple Biotech, was first approved by FDA on May 31, 2018, with 2 approved supplements and 0 published complete response letters.

First approved: May 31, 2018
Review: Standard
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
May 31, 2018	Original applicationNew combination · Standard review	Approved	Review Letter Label

Products

3 strengths and forms


ConsensiEQ 2.5MG BASE;200MG · tablet;oral	Amlodipine Besylate; Celecoxib	DiscontinuedReference drug
ConsensiEQ 5MG BASE;200MG · tablet;oral	Amlodipine Besylate; Celecoxib	DiscontinuedReference drug
ConsensiEQ 10MG BASE;200MG · tablet;oral	Amlodipine Besylate; Celecoxib	DiscontinuedReference drug

All 3 submissions, including labeling and manufacturing supplements


Apr 28, 2021	Supplement 9Labeling · Standard review	Approved	Label Medication Guide Letter
May 12, 2020	Supplement 6Labeling · Standard review	Approved	Label Letter
May 31, 2018	Original applicationNew combination · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 210045
Drugs@FDA: Overview at FDA
Company: Purple Biotech

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters