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FDA NDA · NDA020511

APHTHASOL

Sponsor: ULURU

APPLICATION
NDA020511
TYPE
NDA
ORIGINAL APPROVAL
1996-12-17
LATEST ACTION
2002-06-11
ROUTE
DENTAL
DOSAGE FORM
PASTE
MARKETING STATUS
Discontinued

Products

APHTHASOLDiscontinued
AMLEXANOX 5% · PASTE · DENTAL

Approval history

2002-06-11Labeling · Supplement 2 · standard — Label ↗AP
2001-02-07Manufacturing (CMC) · Supplement 3 · priorityAP
1998-11-10Manufacturing (CMC) · Supplement 1 · priorityAP
1996-12-17Type 1 - New Molecular Entity · Original · priority — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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