← FDA DRUG APPROVALS
FDA ANDA · ANDA079235
CITANEST PLAIN
prilocaine hydrochloride
Sponsor: SEPTODONT INC
APPLICATION
ANDA079235
TYPE
ANDA
ORIGINAL APPROVAL
2010-09-29
LATEST ACTION
2018-11-02
ROUTE
SUBMUCOSAL, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
PRILOCAINE HYDROCHLORIDEPrescription
PRILOCAINE HYDROCHLORIDE 4% · INJECTABLE · INJECTION
Approval history
2018-11-02Labeling · Supplement 5 · 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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