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FDA NDA · NDA019024

PHYSIOLYTE

sodium chloride, sodium gluconate, sodium acetate, potassium chloride, and magnesium chloride

Sponsor: B BRAUN

APPLICATION
NDA019024
TYPE
NDA
ORIGINAL APPROVAL
1984-06-08
LATEST ACTION
2013-05-08
ROUTE
IRRIGATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

PHYSIOLYTE IN PLASTIC CONTAINERPrescription
MAGNESIUM CHLORIDE 30MG/100ML, POTASSIUM CHLORIDE 37MG/100ML, SODIUM ACETATE 370MG/100ML, SODIUM CHLORIDE 530MG/100ML, SODIUM GLUCONATE 500MG/100ML · SOLUTION · IRRIGATION

Approval history

2013-05-08Manufacturing (CMC) · Supplement 21 · standardAP
2003-10-22Labeling · Supplement 15 · standard — Letter ↗AP
2002-07-08Manufacturing (CMC) · Supplement 14 · standardAP
2002-04-03Manufacturing (CMC) · Supplement 13 · standardAP
1999-05-04Manufacturing (CMC) · Supplement 12 · standardAP
1999-03-18Manufacturing (CMC) · Supplement 8 · standardAP
1998-03-25Manufacturing (CMC) · Supplement 11 · standardAP
1995-10-26Manufacturing (CMC) · Supplement 10 · standardAP
1995-09-13Manufacturing (CMC) · Supplement 9 · standardAP
1990-09-11Manufacturing (CMC) · Supplement 7 · standardAP
1988-04-19Manufacturing (CMC) · Supplement 5 · standardAP
1987-03-05Manufacturing (CMC) · Supplement 2 · standardAP
1985-09-18Manufacturing (CMC) · Supplement 1 · standardAP
1984-06-08Type 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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