Prestalia

NDA 205003, held by Adhera. Amlodipine Besylate; Perindopril Arginine.

As of Nov 14, 2026, NDA 205003 (Prestalia), held by Adhera, was first approved by FDA on Jan 21, 2015, with 3 approved supplements and 0 published complete response letters.

First approved: Jan 21, 2015
Review: Standard
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Jan 21, 2015	Original applicationNew combination · Standard review	Approved	Review Letter Label

Products

3 strengths and forms


PrestaliaEQ 2.5MG BASE;3.5MG · tablet;oral	Amlodipine Besylate; Perindopril Arginine	DiscontinuedReference drug
PrestaliaEQ 5MG BASE;7MG · tablet;oral	Amlodipine Besylate; Perindopril Arginine	DiscontinuedReference drug
PrestaliaEQ 10MG BASE;14MG · tablet;oral	Amlodipine Besylate; Perindopril Arginine	DiscontinuedReference drug

All 4 submissions, including labeling and manufacturing supplements


Sep 29, 2017	Supplement 3Labeling · Standard review	Approved	Label Letter
Nov 23, 2016	Supplement 2Labeling · Standard review	Approved	Label Letter
Aug 25, 2015	Supplement 1Labeling · Standard review	Approved	Letter Label
Jan 21, 2015	Original applicationNew combination · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 205003
Drugs@FDA: Overview at FDA
Company: Adhera Therapeutics

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