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FDA NDA · NDA203697

VAZALORE

Sponsor: PLX PHARMA

APPLICATION
NDA203697
TYPE
NDA
ORIGINAL APPROVAL
2013-01-14
LATEST ACTION
2022-10-03
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Over-the-counter

Products

VAZALORE · ReferenceOver-the-counter
ASPIRIN 81MG · CAPSULE · ORAL
VAZALORE · ReferenceOver-the-counter
ASPIRIN 325MG · CAPSULE · ORAL

Approval history

2022-10-03Manufacturing (CMC) · Supplement 9 · standard — Letter ↗AP
2021-11-16Labeling · Supplement 8 · standard — Letter ↗AP
2019-12-11Labeling · Supplement 4 · standard — Letter ↗AP
2018-07-25Labeling · Supplement 3 · standard — Letter ↗AP
2017-11-20Labeling · Supplement 2 · standard — Label ↗AP
2014-01-03Manufacturing (CMC) · Supplement 1 · standardAP
2013-01-14Type 3 - New Dosage Form · Original · standard — Label ↗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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