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FDA NDA · NDA022114

ZINGO

Sponsor: POWDER PHARMS

APPLICATION
NDA022114
TYPE
NDA
ORIGINAL APPROVAL
2007-08-16
LATEST ACTION
2025-12-19
ROUTE
INTRADERMAL
DOSAGE FORM
SYSTEM
MARKETING STATUS
Prescription

Products

ZINGOPrescription
LIDOCAINE HYDROCHLORIDE 0.5MG · SYSTEM · INTRADERMAL

Approval history

2025-12-19Labeling · Supplement 6 · standard — Label ↗AP
2018-11-02Labeling · Supplement 4 · standard — Label ↗AP
2014-09-29Manufacturing (CMC) · Supplement 3 · standardAP
2013-07-24Manufacturing (CMC) · Supplement 2 · standardAP
2009-01-08Efficacy · Supplement 1 · unknown — Label ↗AP
2007-08-16Type 3 - New Dosage Form · Original · standard — Label ↗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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