APPLICATION
ANDA040014
TYPE
ANDA
ORIGINAL APPROVAL
1995-07-10
LATEST ACTION
2018-11-02
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
LIDOCAINE HYDROCHLORIDEDiscontinued
LIDOCAINE HYDROCHLORIDE 2% · SOLUTION · ORAL
Approval history
2018-11-02Labeling · Supplement 8 · standardAP
2018-11-01Labeling · Supplement 7 · standardAP
2015-04-02Labeling · Supplement 6 · standardAP
2015-03-24Manufacturing (CMC) · Supplement 4AP
1997-08-25Manufacturing (CMC) · Supplement 1AP
1995-07-10OriginalAP
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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