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FDA ANDA · ANDA212821

LIDOCAINE HYDROCHLORIDE

Sponsor: HUONS

APPLICATION
ANDA212821
TYPE
ANDA
ORIGINAL APPROVAL
2020-05-07
LATEST ACTION
2023-10-18
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

LIDOCAINE HYDROCHLORIDEPrescription
LIDOCAINE HYDROCHLORIDE 1% · INJECTABLE · INJECTION
LIDOCAINE HYDROCHLORIDEPrescription
LIDOCAINE HYDROCHLORIDE 2% · INJECTABLE · INJECTION

Approval history

2023-10-18Manufacturing (CMC) · Supplement 4 · unknownAP
2021-06-01Manufacturing (CMC) · Supplement 1 · standardAP
2020-05-07UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

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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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