APPLICATION
ANDA088802
TYPE
ANDA
ORIGINAL APPROVAL
1985-04-26
LATEST ACTION
2018-11-02
ROUTE
ORAL, TOPICAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
LIDOCAINE VISCOUSPrescription
LIDOCAINE HYDROCHLORIDE 2% · SOLUTION · ORAL
Approval history
2018-11-02Labeling · Supplement 25 · standardAP
2014-11-17Labeling · Supplement 23 · standardAP
2008-06-30Labeling · Supplement 20AP
2002-02-14Manufacturing (CMC) · Supplement 17AP
1998-06-15Manufacturing (CMC) · Supplement 16AP
1996-08-28Manufacturing (CMC) · Supplement 14AP
1996-03-29Labeling · Supplement 13AP
1995-06-30Manufacturing (CMC) · Supplement 12AP
1994-06-01Manufacturing (CMC) · Supplement 11AP
1991-06-12Labeling · Supplement 10AP
1991-03-21Labeling · Supplement 9AP
1990-11-16Labeling · Supplement 8AP
1988-10-11Manufacturing (CMC) · Supplement 6AP
1987-10-27Manufacturing (CMC) · Supplement 3AP
1987-10-27Manufacturing (CMC) · Supplement 4AP
1986-04-17Manufacturing (CMC) · Supplement 2AP
1985-04-26OriginalAP
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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