FDA NDA · NDA019686

POTASSIUM CHLORIDE IN SODIUM CHLORIDE

sodium chloride and potassium chloride

Sponsor: OTSUKA ICU MEDCL

APPLICATION

NDA019686

TYPE

NDA

ORIGINAL APPROVAL

1988-10-17

LATEST ACTION

2015-09-10

ROUTE

INTRAVENOUS, INJECTION

DOSAGE FORM

INJECTABLE

MARKETING STATUS

Prescription

Products

POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERPrescription

POTASSIUM CHLORIDE 149MG/100ML, SODIUM CHLORIDE 900MG/100ML · INJECTABLE · INJECTION

POTASSIUM CHLORIDE 40MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERPrescription

POTASSIUM CHLORIDE 298MG/100ML, SODIUM CHLORIDE 900MG/100ML · INJECTABLE · INJECTION

2015-09-10Manufacturing (CMC) · Supplement 32 · standardAP

2014-09-08Manufacturing (CMC) · Supplement 29 · standardAP

1999-05-19Labeling · Supplement 11AP

1996-08-29Manufacturing (CMC) · Supplement 8 · standardAP

1996-08-27Manufacturing (CMC) · Supplement 7 · standardAP

1996-08-06Manufacturing (CMC) · Supplement 10 · standardAP

1995-08-14Manufacturing (CMC) · Supplement 9 · standardAP

1992-01-28Manufacturing (CMC) · Supplement 5 · standardAP

1991-09-10Manufacturing (CMC) · Supplement 4 · standardAP

1990-02-22Manufacturing (CMC) · Supplement 1 · standardAP

1990-01-11Manufacturing (CMC) · Supplement 2 · standardAP

1988-10-17Type 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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