← FDA DRUG APPROVALS
FDA ANDA · ANDA083914
LIDOCAINE HYDROCHLORIDE 5% AND DEXTROSE 7.5%
Sponsor: HOSPIRA
APPLICATION
ANDA083914
TYPE
ANDA
ORIGINAL APPROVAL
1974-01-23
LATEST ACTION
2018-11-02
ROUTE
SPINAL
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
LIDOCAINE HYDROCHLORIDE 5% AND DEXTROSE 7.5% · ReferencePrescription
LIDOCAINE HYDROCHLORIDE 5% · INJECTABLE · SPINAL
Approval history
2018-11-02Labeling · Supplement 40 · standardAP
2010-04-08Labeling · Supplement 32AP
1997-02-24Manufacturing (CMC) · Supplement 24AP
1996-10-03Manufacturing (CMC) · Supplement 23AP
1996-04-24Labeling · Supplement 22AP
1995-11-02Manufacturing (CMC) · Supplement 20AP
1989-08-07Labeling · Supplement 19AP
1989-06-13Manufacturing (CMC) · Supplement 18AP
1988-12-20Labeling · Supplement 17AP
1985-08-09Manufacturing (CMC) · Supplement 16AP
1984-10-18Manufacturing (CMC) · Supplement 15AP
1982-09-23Manufacturing (CMC) · Supplement 13AP
1982-07-22Manufacturing (CMC) · Supplement 12AP
1982-07-22Manufacturing (CMC) · Supplement 11AP
1974-01-23OriginalAP
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.