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FDA NDA · NDA205003

PRESTALIA

Sponsor: ADHERA

APPLICATION
NDA205003
TYPE
NDA
ORIGINAL APPROVAL
2015-01-21
LATEST ACTION
2017-09-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

PRESTALIA · ReferenceDiscontinued
AMLODIPINE BESYLATE EQ 5MG BASE, PERINDOPRIL ARGININE 7MG · TABLET · ORAL
PRESTALIA · ReferenceDiscontinued
AMLODIPINE BESYLATE EQ 10MG BASE, PERINDOPRIL ARGININE 14MG · TABLET · ORAL
PRESTALIA · ReferenceDiscontinued
AMLODIPINE BESYLATE EQ 2.5MG BASE, PERINDOPRIL ARGININE 3.5MG · TABLET · ORAL

Approval history

2017-09-29Labeling · Supplement 3 · standard — Label ↗AP
2016-11-23Labeling · Supplement 2 · standard — Letter ↗AP
2015-08-25Labeling · Supplement 1 · standard — Letter ↗AP
2015-01-21Type 4 - New Combination · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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