APPLICATION
ANDA060567
TYPE
ANDA
ORIGINAL APPROVAL
1964-09-15
LATEST ACTION
2004-04-07
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
TERRAMYCINDiscontinued
LIDOCAINE HYDROCHLORIDE 2%, OXYTETRACYCLINE 125MG/ML · INJECTABLE · INJECTION
TERRAMYCINDiscontinued
LIDOCAINE HYDROCHLORIDE 2%, OXYTETRACYCLINE 50MG/ML · INJECTABLE · INJECTION
Approval history
2004-04-07Labeling · Supplement 7AP
1995-07-11Manufacturing (CMC) · Supplement 6AP
1989-08-03Manufacturing (CMC) · Supplement 5AP
1964-09-15OriginalAP
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.