← FDA DRUG APPROVALS

FDA NDA · NDA020971

ARTICAINE

articaine hydrochloride and epinephrine

Sponsor: DEPROCO

APPLICATION
NDA020971
TYPE
NDA
ORIGINAL APPROVAL
2000-04-03
LATEST ACTION
2018-11-02
ROUTE
SUBMUCOSAL, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

SEPTOCAINE · ReferencePrescription
ARTICAINE HYDROCHLORIDE 4%, EPINEPHRINE BITARTRATE EQ 0.0085MG BASE/1.7ML (4% · INJECTABLE · INJECTION
SEPTOCAINE · ReferencePrescription
ARTICAINE HYDROCHLORIDE 4%, EPINEPHRINE BITARTRATE EQ 0.017MG BASE/1.7ML (4% · INJECTABLE · INJECTION

Approval history

2018-11-02Labeling · Supplement 42 · standard — Label ↗AP
2017-01-12Manufacturing (CMC) · Supplement 36 · standardAP
2016-10-27Manufacturing (CMC) · Supplement 35AP
2015-01-26Manufacturing (CMC) · Supplement 34 · standardAP
2014-06-05Manufacturing (CMC) · Supplement 32 · standardAP
2014-06-05Manufacturing (CMC) · Supplement 33 · standardAP
2014-02-14Manufacturing (CMC) · Supplement 29 · standardAP
2014-01-31Manufacturing (CMC) · Supplement 30 · standardAP
2013-03-08Manufacturing (CMC) · Supplement 28 · standardAP
2010-11-12Labeling · Supplement 23 · standard — Letter ↗AP
2010-02-22Labeling · Supplement 21 · standard — Letter ↗AP
2006-11-09Labeling · Supplement 17 · standard — Label ↗AP
2006-03-30Labeling · Supplement 15 · standardAP
2006-03-30Labeling · Supplement 13 · standard — Review ↗AP
2005-02-04Labeling · Supplement 9 · standard — Review ↗AP
2004-10-14Labeling · Supplement 7 · standard — Letter ↗AP
2002-07-23Manufacturing (CMC) · Supplement 1 · standardAP
2000-04-03Type 1 - New Molecular Entity and Type 4 - New Combination · Original · standard — Letter ↗AP
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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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