APPLICATION
ANDA080618
TYPE
ANDA
ORIGINAL APPROVAL
1972-08-14
LATEST ACTION
2014-09-22
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
PYRIDOXINE HYDROCHLORIDE · ReferencePrescription
PYRIDOXINE HYDROCHLORIDE 100MG/ML · INJECTABLE · INJECTION
Approval history
2014-09-22Labeling · Supplement 31AP
2005-07-14Labeling · Supplement 29AP
1997-11-25Manufacturing (CMC) · Supplement 23AP
1996-07-22Manufacturing (CMC) · Supplement 21AP
1996-07-22Manufacturing (CMC) · Supplement 20AP
1996-07-22Manufacturing (CMC) · Supplement 19AP
1995-01-18Manufacturing (CMC) · Supplement 22AP
1991-03-20Manufacturing (CMC) · Supplement 18AP
1983-10-07Manufacturing (CMC) · Supplement 16AP
1983-08-10Manufacturing (CMC) · Supplement 15AP
1983-07-26Manufacturing (CMC) · Supplement 14AP
1972-08-14OriginalAP
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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