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FDA ANDA · ANDA088586

LIDOCAINE

lidocaine hydrochloride

Sponsor: FRESENIUS KABI USA

APPLICATION
ANDA088586
TYPE
ANDA
ORIGINAL APPROVAL
1985-07-24
LATEST ACTION
2010-05-18
ROUTE
INFILTRATION, PERINEURAL, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

LIDOCAINE HYDROCHLORIDEPrescription
LIDOCAINE HYDROCHLORIDE 1% · INJECTABLE · INJECTION
LIDOCAINE HYDROCHLORIDEPrescription
LIDOCAINE HYDROCHLORIDE 2% · INJECTABLE · INJECTION
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINERPrescription
LIDOCAINE HYDROCHLORIDE 1% · INJECTABLE · INJECTION

Approval history

2010-05-18Labeling · Supplement 22AP
2007-05-21Manufacturing (CMC) · Supplement 20AP
2000-12-29Labeling · Supplement 16AP
2000-03-01Manufacturing (CMC) · Supplement 12AP
1995-03-08Manufacturing (CMC) · Supplement 13AP
1992-07-28Labeling · Supplement 14AP
1988-04-22Manufacturing (CMC) · Supplement 5AP
1988-04-22Manufacturing (CMC) · Supplement 3AP
1988-04-22Manufacturing (CMC) · Supplement 4AP
1988-03-15Manufacturing (CMC) · Supplement 10AP
1988-03-15Manufacturing (CMC) · Supplement 8AP
1988-03-15Manufacturing (CMC) · Supplement 11AP
1988-03-15Manufacturing (CMC) · Supplement 9AP
1987-01-15Manufacturing (CMC) · Supplement 7AP
1985-12-12Manufacturing (CMC) · Supplement 2AP
1985-07-24OriginalAP
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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