APPLICATION
ANDA085362
TYPE
ANDA
ORIGINAL APPROVAL
1979-11-15
LATEST ACTION
2001-02-14
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
NOVOCAINDiscontinued
PROCAINE HYDROCHLORIDE 1% · INJECTABLE · INJECTION
NOVOCAINDiscontinued
PROCAINE HYDROCHLORIDE 2% · INJECTABLE · INJECTION
Approval history
2001-02-14Manufacturing (CMC) · Supplement 11AP
1998-08-07Manufacturing (CMC) · Supplement 9AP
1995-12-11Manufacturing (CMC) · Supplement 7AP
1995-12-11Manufacturing (CMC) · Supplement 8AP
1988-08-12Manufacturing (CMC) · Supplement 6AP
1988-08-12Manufacturing (CMC) · Supplement 4AP
1979-11-15OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.