APPLICATION
ANDA219535
TYPE
ANDA
ORIGINAL APPROVAL
2025-04-02
LATEST ACTION
2025-10-02
ROUTE
INFILTRATION, PERINEURAL, EPIDURAL, INTRACAUDAL, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
LIDOCAINE HYDROCHLORIDEPrescription
LIDOCAINE HYDROCHLORIDE 1% · INJECTABLE · INJECTION
LIDOCAINE HYDROCHLORIDEPrescription
LIDOCAINE HYDROCHLORIDE 2% · INJECTABLE · INJECTION
Approval history
2025-10-02Manufacturing (CMC) · Supplement 7 · unknownAP
2025-04-02UNKNOWN · Original · standardAP
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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