APPLICATION
ANDA080572
TYPE
ANDA
ORIGINAL APPROVAL
1974-02-13
LATEST ACTION
1999-02-19
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
PYRIDOXINE HYDROCHLORIDEDiscontinued
PYRIDOXINE HYDROCHLORIDE 100MG/ML · INJECTABLE · INJECTION
Approval history
1999-02-19Manufacturing (CMC) · Supplement 147AP
1999-02-02Manufacturing (CMC) · Supplement 146AP
1996-08-28Manufacturing (CMC) · Supplement 145AP
1990-12-26Labeling · Supplement 144AP
1989-04-03Manufacturing (CMC) · Supplement 143AP
1988-08-03Manufacturing (CMC) · Supplement 140AP
1988-08-03Manufacturing (CMC) · Supplement 141AP
1986-06-16Manufacturing (CMC) · Supplement 138AP
1974-02-13OriginalAP
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.