APPLICATION
ANDA086364
TYPE
ANDA
ORIGINAL APPROVAL
1980-03-06
LATEST ACTION
2015-08-18
ROUTE
TOPICAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
LARYNG-O-JET KITPrescription
LIDOCAINE HYDROCHLORIDE 4% · SOLUTION · TOPICAL
Approval history
2015-08-18Labeling · Supplement 35 · standardAP
1998-01-14Manufacturing (CMC) · Supplement 22AP
1997-12-17Manufacturing (CMC) · Supplement 25AP
1995-09-19Manufacturing (CMC) · Supplement 24AP
1994-06-20Manufacturing (CMC) · Supplement 23AP
1993-10-29Manufacturing (CMC) · Supplement 21AP
1993-03-19Manufacturing (CMC) · Supplement 20AP
1992-09-03Labeling · Supplement 19AP
1989-08-29Labeling · Supplement 18AP
1987-10-19Manufacturing (CMC) · Supplement 16AP
1985-11-01Manufacturing (CMC) · Supplement 10AP
1985-08-13Manufacturing (CMC) · Supplement 6AP
1982-11-12Manufacturing (CMC) · Supplement 5AP
1982-10-01Manufacturing (CMC) · Supplement 2AP
1980-03-06OriginalAP
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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