APPLICATION
NDA018336
TYPE
NDA
ORIGINAL APPROVAL
1981-10-06
LATEST ACTION
2001-08-14
ROUTE
IRRIGATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
TIS-U-SOL IN PLASTIC CONTAINERPrescription
MAGNESIUM SULFATE 20MG/100ML, POTASSIUM CHLORIDE 40MG/100ML, POTASSIUM PHOSPHATE, MONOBASIC 6.25MG/100ML, SODIUM CHLORIDE 800MG/100ML, SODIUM PHOSPHATE 8.75MG/100ML · SOLUTION · IRRIGATION
Approval history
2001-08-14Manufacturing (CMC) · Supplement 27 · standardAP
1999-11-24Manufacturing (CMC) · Supplement 26 · standardAP
1997-04-29Manufacturing (CMC) · Supplement 25 · standardAP
1994-09-30Manufacturing (CMC) · Supplement 23 · standardAP
1994-02-18Manufacturing (CMC) · Supplement 24 · standardAP
1993-12-08Manufacturing (CMC) · Supplement 22 · standardAP
1991-03-26Manufacturing (CMC) · Supplement 20 · standardAP
1991-02-15Manufacturing (CMC) · Supplement 18 · standardAP
1990-05-18Manufacturing (CMC) · Supplement 19 · standardAP
1989-07-26Manufacturing (CMC) · Supplement 17 · standardAP
1987-07-25Manufacturing (CMC) · Supplement 15 · standardAP
1987-05-28Manufacturing (CMC) · Supplement 14 · standardAP
1986-02-27Manufacturing (CMC) · Supplement 13 · standardAP
1985-08-28Manufacturing (CMC) · Supplement 7 · standardAP
1985-08-28Manufacturing (CMC) · Supplement 6 · standardAP
1985-06-26Labeling · Supplement 12AP
1985-06-13Manufacturing (CMC) · Supplement 11 · standardAP
1985-01-24Manufacturing (CMC) · Supplement 8 · standardAP
1984-08-24Manufacturing (CMC) · Supplement 1 · standardAP
1984-03-16Manufacturing (CMC) · Supplement 5 · standardAP
1984-02-28Manufacturing (CMC) · Supplement 10 · standardAP
1982-05-17Labeling · Supplement 3AP
1981-10-06Type 5 - New Formulation or New Manufacturer · Original · standardAP
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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