APPLICATION
ANDA080571
TYPE
ANDA
ORIGINAL APPROVAL
1974-02-26
LATEST ACTION
1999-02-19
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
THIAMINE HYDROCHLORIDEPrescription
THIAMINE HYDROCHLORIDE 100MG/ML · INJECTABLE · INJECTION
THIAMINE HYDROCHLORIDEPrescription
THIAMINE HYDROCHLORIDE 200MG/ML · INJECTABLE · INJECTION
Approval history
1999-02-19Manufacturing (CMC) · Supplement 144AP
1999-02-02Manufacturing (CMC) · Supplement 142AP
1996-08-28Manufacturing (CMC) · Supplement 141AP
1994-11-14Labeling · Supplement 140AP
1992-12-14Manufacturing (CMC) · Supplement 139AP
1992-09-22Manufacturing (CMC) · Supplement 136AP
1992-09-22Manufacturing (CMC) · Supplement 137AP
1992-09-22Manufacturing (CMC) · Supplement 135AP
1988-01-11Manufacturing (CMC) · Supplement 133AP
1986-05-28Manufacturing (CMC) · Supplement 131AP
1985-12-13Manufacturing (CMC) · Supplement 130AP
1985-12-13Manufacturing (CMC) · Supplement 129AP
1974-02-26OriginalAP
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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