APPLICATION
ANDA206297
TYPE
ANDA
ORIGINAL APPROVAL
2015-08-07
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 8 · standardAP
2018-04-09Labeling · Supplement 7 · standardAP
2017-06-20Manufacturing (CMC) · Supplement 5 · unknownAP
2017-06-20Manufacturing (CMC) · Supplement 3 · unknownAP
2017-06-20Labeling · Supplement 2 · standardAP
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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