FDA NDA · NDA018896

POTASSIUM ACETATE

Sponsor: HOSPIRA

APPLICATION

NDA018896

TYPE

NDA

ORIGINAL APPROVAL

1984-07-20

LATEST ACTION

2014-06-12

ROUTE

INTRAVENOUS, INJECTION

DOSAGE FORM

INJECTABLE

MARKETING STATUS

Prescription

Products

POTASSIUM ACETATE · ReferencePrescription

POTASSIUM ACETATE 2MEQ/ML · INJECTABLE · INJECTION

2014-06-12Manufacturing (CMC) · Supplement 22 · standardAP

2002-12-24Manufacturing (CMC) · Supplement 12 · standard — Review ↗AP

2001-02-16Manufacturing (CMC) · Supplement 11 · standard — Review ↗AP

2000-02-11Labeling · Supplement 8 · standardAP

1999-08-31Manufacturing (CMC) · Supplement 10 · standardAP

1999-01-22Manufacturing (CMC) · Supplement 9 · standardAP

1998-08-13Labeling · Supplement 7 · standardAP

1997-01-17Manufacturing (CMC) · Supplement 5 · standardAP

1996-08-29Manufacturing (CMC) · Supplement 6 · standardAP

1988-10-21Manufacturing (CMC) · Supplement 3 · standardAP

1987-12-11Manufacturing (CMC) · Supplement 2 · standardAP

1986-07-24Manufacturing (CMC) · Supplement 1 · standardAP

1984-07-20Type 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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