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FDA NDA · NDA018508

TIS-U-SOL

sodium chloride, potassium chloride, magnesium sulfate, sodium phosphate, and potassium phosphate

Sponsor: BAXTER HLTHCARE

APPLICATION
NDA018508
TYPE
NDA
ORIGINAL APPROVAL
1982-02-19
LATEST ACTION
2015-06-26
ROUTE
IRRIGATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

TIS-U-SOLPrescription
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

2015-06-26Manufacturing (CMC) · Supplement 22 · standardAP
2015-02-03Manufacturing (CMC) · Supplement 21 · standardAP
2011-09-28Manufacturing (CMC) · Supplement 19AP
1994-09-30Manufacturing (CMC) · Supplement 12 · standardAP
1993-09-14Manufacturing (CMC) · Supplement 13 · standardAP
1991-11-14Manufacturing (CMC) · Supplement 10 · standardAP
1991-03-26Manufacturing (CMC) · Supplement 11 · standardAP
1990-05-18Manufacturing (CMC) · Supplement 9 · standardAP
1989-07-26Manufacturing (CMC) · Supplement 8 · standardAP
1986-10-30Manufacturing (CMC) · Supplement 7 · standardAP
1985-06-26Labeling · Supplement 6AP
1985-01-24Manufacturing (CMC) · Supplement 2 · standardAP
1984-02-28Manufacturing (CMC) · Supplement 4 · standardAP
1982-02-19Type 5 - New Formulation or New Manufacturer · Original · standardAP
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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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