APPLICATION
NDA017637
TYPE
NDA
ORIGINAL APPROVAL
1978-02-08
LATEST ACTION
2014-06-12
ROUTE
IRRIGATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
PHYSIOSOL IN PLASTIC CONTAINERPrescription
MAGNESIUM CHLORIDE 30MG/100ML, POTASSIUM CHLORIDE 37MG/100ML, SODIUM ACETATE 222MG/100ML, SODIUM CHLORIDE 526MG/100ML, SODIUM GLUCONATE 502MG/100ML · SOLUTION · IRRIGATION
Approval history
2014-06-12Manufacturing (CMC) · Supplement 61 · standardAP
2000-02-23Labeling · Supplement 46 · standardAP
1999-06-04Manufacturing (CMC) · Supplement 47 · standardAP
1998-05-12Labeling · Supplement 44 · standardAP
1998-02-04Manufacturing (CMC) · Supplement 45 · standardAP
1996-08-27Manufacturing (CMC) · Supplement 43 · standardAP
1993-08-24Manufacturing (CMC) · Supplement 40 · standardAP
1992-06-30Manufacturing (CMC) · Supplement 41 · standardAP
1988-11-25Manufacturing (CMC) · Supplement 39 · standardAP
1986-01-31Manufacturing (CMC) · Supplement 38 · standardAP
1986-01-18Manufacturing (CMC) · Supplement 35 · standardAP
1985-10-29Manufacturing (CMC) · Supplement 37 · standardAP
1984-11-09Manufacturing (CMC) · Supplement 34 · standardAP
1984-10-22Manufacturing (CMC) · Supplement 33 · standardAP
1984-08-25Manufacturing (CMC) · Supplement 31 · standardAP
1984-03-15Manufacturing (CMC) · Supplement 30 · standardAP
1984-03-01Manufacturing (CMC) · Supplement 28 · standardAP
1982-07-08Labeling · Supplement 25AP
1982-06-18Manufacturing (CMC) · Supplement 29 · standardAP
1982-06-10Manufacturing (CMC) · Supplement 27 · standardAP
1981-11-06Manufacturing (CMC) · Supplement 26 · standardAP
1981-07-21Manufacturing (CMC) · Supplement 18 · standardAP
1980-10-01Labeling · Supplement 24AP
1980-09-08Manufacturing (CMC) · Supplement 23 · standardAP
1980-06-06Manufacturing (CMC) · Supplement 22 · standardAP
1980-06-06Manufacturing (CMC) · Supplement 20 · standardAP
1980-05-23Manufacturing (CMC) · Supplement 19 · standardAP
1980-03-20Manufacturing (CMC) · Supplement 17 · standardAP
1979-10-04Manufacturing (CMC) · Supplement 14 · standardAP
1979-07-31Manufacturing (CMC) · Supplement 13 · standardAP
1979-07-18Manufacturing (CMC) · Supplement 12 · standardAP
1979-04-30Manufacturing (CMC) · Supplement 9 · standardAP
1979-02-02Manufacturing (CMC) · Supplement 10 · standardAP
1979-01-05Manufacturing (CMC) · Supplement 11 · standardAP
1978-12-01Manufacturing (CMC) · Supplement 8 · standardAP
1978-11-22Manufacturing (CMC) · Supplement 6 · standardAP
1978-11-22Labeling · Supplement 7AP
1978-09-08Labeling · Supplement 2AP
1978-09-08Labeling · Supplement 5AP
1978-08-29Manufacturing (CMC) · Supplement 4 · 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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