APPLICATION
ANDA080575
TYPE
ANDA
ORIGINAL APPROVAL
1975-06-24
LATEST ACTION
2020-09-28
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
THIAMINE HYDROCHLORIDEPrescription
THIAMINE HYDROCHLORIDE 100MG/ML · INJECTABLE · INJECTION
Approval history
2020-09-28Manufacturing (CMC) · Supplement 19 · unknownAP
2000-10-27Manufacturing (CMC) · Supplement 18AP
1997-09-08Manufacturing (CMC) · Supplement 17AP
1996-02-27Manufacturing (CMC) · Supplement 16AP
1991-04-23Labeling · Supplement 15AP
1988-12-19Labeling · Supplement 14AP
1986-11-03Manufacturing (CMC) · Supplement 10AP
1986-11-03Manufacturing (CMC) · Supplement 11AP
1983-09-13Manufacturing (CMC) · Supplement 8AP
1982-09-22Manufacturing (CMC) · Supplement 6AP
1975-06-24OriginalAP
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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