APPLICATION
ANDA087872
TYPE
ANDA
ORIGINAL APPROVAL
1982-11-18
LATEST ACTION
2018-11-02
ROUTE
ORAL, TOPICAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
LIDOCAINE HYDROCHLORIDEPrescription
LIDOCAINE HYDROCHLORIDE 2% · SOLUTION · ORAL
Approval history
2018-11-02Labeling · Supplement 24 · standardAP
2014-12-01Labeling · Supplement 23 · standardAP
2003-12-18Labeling · Supplement 22AP
2003-01-10Labeling · Supplement 21AP
1996-12-02Manufacturing (CMC) · Supplement 15AP
1996-12-02Manufacturing (CMC) · Supplement 13AP
1996-12-02Manufacturing (CMC) · Supplement 16AP
1996-12-02Manufacturing (CMC) · Supplement 14AP
1996-12-02Labeling · Supplement 17AP
1994-04-12Labeling · Supplement 12AP
1993-09-08Manufacturing (CMC) · Supplement 9AP
1991-10-10Labeling · Supplement 11AP
1990-04-04Labeling · Supplement 10AP
1990-04-04Labeling · Supplement 27AP
1987-05-14Manufacturing (CMC) · Supplement 7AP
1986-04-30Manufacturing (CMC) · Supplement 6AP
1984-10-18Manufacturing (CMC) · Supplement 2AP
1984-10-18Manufacturing (CMC) · Supplement 3AP
1983-10-03Manufacturing (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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