APPLICATION
ANDA087881
TYPE
ANDA
ORIGINAL APPROVAL
1982-11-18
LATEST ACTION
2015-10-19
ROUTE
TOPICAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
LIDOCAINE HYDROCHLORIDEPrescription
LIDOCAINE HYDROCHLORIDE 4% · SOLUTION · TOPICAL
Approval history
2015-10-19Labeling · Supplement 12 · standardAP
2002-08-13Manufacturing (CMC) · Supplement 11AP
2002-04-15Manufacturing (CMC) · Supplement 10 · unknownAP
1994-02-16Labeling · Supplement 9AP
1992-05-28Labeling · Supplement 8AP
1989-09-06Labeling · Supplement 7AP
1987-05-14Manufacturing (CMC) · Supplement 3AP
1983-10-06Manufacturing (CMC) · Supplement 1AP
1982-11-18OriginalAP
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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