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FDA NDA · NDA021383

CITANEST FORTE DENTAL

Sponsor: DENTSPLY PHARM

APPLICATION
NDA021383
TYPE
NDA
ORIGINAL APPROVAL
1965-11-18
LATEST ACTION
2021-11-03
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

CITANEST FORTE DENTAL · ReferencePrescription
EPINEPHRINE BITARTRATE 0.005MG/ML, PRILOCAINE HYDROCHLORIDE 4% · INJECTABLE · INJECTION

Approval history

2021-11-03Labeling · Supplement 10 · standard — Letter ↗AP
2018-11-02Labeling · Supplement 11 · standard — Label ↗AP
2015-03-03Manufacturing (CMC) · Supplement 9AP
2014-08-29Manufacturing (CMC) · Supplement 8AP
1965-11-18UNKNOWN · Original · unknownAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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