APPLICATION
NDA013025
TYPE
NDA
ORIGINAL APPROVAL
1965-12-16
LATEST ACTION
2013-11-08
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
SOLUTION, INJECTABLE
MARKETING STATUS
Prescription, Discontinued
Products
THAM · ReferencePrescription
TROMETHAMINE 18GM/500ML (3.6GM/100ML) · SOLUTION · INJECTION
THAM-EDiscontinued
POTASSIUM CHLORIDE 370MG/VIAL, SODIUM CHLORIDE 1.75GM/VIAL, TROMETHAMINE 36GM/VIAL · INJECTABLE · INJECTION
Approval history
2013-11-08Manufacturing (CMC) · Supplement 55 · priorityAP
2013-06-25Manufacturing (CMC) · Supplement 54 · priorityAP
2000-07-26Labeling · Supplement 35 · standardAP
2000-02-11Labeling · Supplement 37 · standardAP
1998-02-12Manufacturing (CMC) · Supplement 36 · priorityAP
1996-03-29Manufacturing (CMC) · Supplement 34 · priorityAP
1994-09-30Manufacturing (CMC) · Supplement 33 · priorityAP
1989-01-27Manufacturing (CMC) · Supplement 32 · priorityAP
1986-06-12Manufacturing (CMC) · Supplement 31 · priorityAP
1986-01-31Manufacturing (CMC) · Supplement 26 · priorityAP
1984-11-09Manufacturing (CMC) · Supplement 25 · priorityAP
1984-08-03Labeling · Supplement 24AP
1984-01-09Manufacturing (CMC) · Supplement 20 · priorityAP
1983-07-05Manufacturing (CMC) · Supplement 23 · priorityAP
1982-09-27Labeling · Supplement 18AP
1982-09-27Labeling · Supplement 19AP
1982-06-18Manufacturing (CMC) · Supplement 22 · priorityAP
1981-12-17Labeling · Supplement 21AP
1980-10-14Manufacturing (CMC) · Supplement 17 · priorityAP
1980-10-06Manufacturing (CMC) · Supplement 16 · priorityAP
1980-06-06Manufacturing (CMC) · Supplement 15 · priorityAP
1980-05-29Manufacturing (CMC) · Supplement 14 · priorityAP
1977-07-27Manufacturing (CMC) · Supplement 13 · priorityAP
1976-12-08Manufacturing (CMC) · Supplement 12 · priorityAP
1976-03-01Manufacturing (CMC) · Supplement 11 · priorityAP
1975-11-14Manufacturing (CMC) · Supplement 10 · priorityAP
1965-12-16Type 1 - New Molecular Entity and Type 4 - New Combination · Original · priorityAP
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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