APPLICATION
ANDA040433
TYPE
ANDA
ORIGINAL APPROVAL
2003-02-12
LATEST ACTION
2025-08-27
ROUTE
TOPICAL
DOSAGE FORM
JELLY
MARKETING STATUS
Prescription
Products
LIDOCAINE HYDROCHLORIDEPrescription
LIDOCAINE HYDROCHLORIDE 2% · JELLY · TOPICAL
Approval history
2025-08-27Manufacturing (CMC) · Supplement 20 · unknownAP
2020-03-25Labeling · Supplement 14 · standardAP
2017-03-10Manufacturing (CMC) · Supplement 12 · unknownAP
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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