APPLICATION
ANDA086724
TYPE
ANDA
ORIGINAL APPROVAL
1981-08-17
LATEST ACTION
2018-11-02
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Prescription
Products
LIDOCAINEPrescription
LIDOCAINE 5% · OINTMENT · TOPICAL
Approval history
2018-11-02Labeling · Supplement 35 · standardAP
2018-11-02Labeling · Supplement 33 · standardAP
2016-09-02Manufacturing (CMC) · Supplement 28 · unknownAP
2006-01-24Labeling · Supplement 20AP
1993-02-16Labeling · Supplement 14AP
1989-09-22Labeling · Supplement 13AP
1989-06-30Manufacturing (CMC) · Supplement 12AP
1989-02-24Manufacturing (CMC) · Supplement 11AP
1986-08-14Manufacturing (CMC) · Supplement 9AP
1986-02-25Manufacturing (CMC) · Supplement 7AP
1986-02-25Manufacturing (CMC) · Supplement 5AP
1986-02-25Manufacturing (CMC) · Supplement 6AP
1984-06-12Manufacturing (CMC) · Supplement 4AP
1982-04-05Manufacturing (CMC) · Supplement 2AP
1982-03-24Manufacturing (CMC) · Supplement 1AP
1981-08-17OriginalAP
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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