APPLICATION
ANDA088803
TYPE
ANDA
ORIGINAL APPROVAL
1985-04-03
LATEST ACTION
2021-08-20
ROUTE
TOPICAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
LIDOCAINE HYDROCHLORIDEPrescription
LIDOCAINE HYDROCHLORIDE 4% · SOLUTION · TOPICAL
Approval history
2021-08-20Labeling · Supplement 17 · standardAP
2008-06-30Labeling · Supplement 13AP
2000-03-27Manufacturing (CMC) · Supplement 10AP
2000-03-27Manufacturing (CMC) · Supplement 9AP
1996-08-28Manufacturing (CMC) · Supplement 8AP
1991-06-18Labeling · Supplement 7AP
1991-03-04Manufacturing (CMC) · Supplement 6AP
1989-08-31Labeling · Supplement 5AP
1988-11-01Bioequivalence · Supplement 2AP
1988-10-17Labeling · Supplement 1AP
1988-09-27Manufacturing (CMC) · Supplement 3AP
1988-09-27Manufacturing (CMC) · Supplement 4AP
1985-04-03OriginalAP
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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