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FDA ANDA · ANDA086578

LIDOCAINE HYDROCHLORIDE VISCOUS

Sponsor: ACTAVIS MID ATLANTIC

APPLICATION
ANDA086578
TYPE
ANDA
ORIGINAL APPROVAL
1980-05-09
LATEST ACTION
2018-11-02
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

LIDOCAINE HYDROCHLORIDE VISCOUSDiscontinued
LIDOCAINE HYDROCHLORIDE 2% · SOLUTION · ORAL

Approval history

2018-11-02Labeling · Supplement 40 · standardAP
2014-12-01Labeling · Supplement 39 · standardAP
2000-11-02Manufacturing (CMC) · Supplement 33AP
2000-10-30Manufacturing (CMC) · Supplement 34AP
2000-10-03Manufacturing (CMC) · Supplement 30AP
2000-10-03Manufacturing (CMC) · Supplement 31AP
1997-06-27Manufacturing (CMC) · Supplement 28AP
1995-04-05Labeling · Supplement 27AP
1994-10-11Manufacturing (CMC) · Supplement 26AP
1994-10-11Manufacturing (CMC) · Supplement 25AP
1992-04-06Manufacturing (CMC) · Supplement 24AP
1991-06-03Labeling · Supplement 21AP
1991-01-14Labeling · Supplement 19AP
1990-09-28Manufacturing (CMC) · Supplement 22AP
1989-10-25Labeling · Supplement 20AP
1989-05-09Manufacturing (CMC) · Supplement 18AP
1988-01-15Manufacturing (CMC) · Supplement 17AP
1986-01-22Manufacturing (CMC) · Supplement 16AP
1986-01-22Manufacturing (CMC) · Supplement 15AP
1983-06-09Manufacturing (CMC) · Supplement 12AP
1982-09-21Manufacturing (CMC) · Supplement 8AP
1982-09-21Manufacturing (CMC) · Supplement 7AP
1982-07-12Manufacturing (CMC) · Supplement 11AP
1982-04-26Manufacturing (CMC) · Supplement 10AP
1982-04-26Manufacturing (CMC) · Supplement 9AP
1980-05-09OriginalAP
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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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