FDA NDA · NDA018792

NEOPHAM 6.4%

Sponsor: HOSPIRA

APPLICATION

NDA018792

TYPE

NDA

ORIGINAL APPROVAL

1984-01-17

LATEST ACTION

1995-02-09

ROUTE

INJECTION

DOSAGE FORM

INJECTABLE

MARKETING STATUS

Discontinued

Products

NEOPHAM 6.4%Discontinued

AMINO ACIDS 6.4% (6.4GM/100ML) · INJECTABLE · INJECTION

1995-02-09Manufacturing (CMC) · Supplement 13 · standardAP

1994-03-30Manufacturing (CMC) · Supplement 11 · standardAP

1993-01-11Manufacturing (CMC) · Supplement 12 · standardAP

1990-04-05Manufacturing (CMC) · Supplement 10 · standardAP

1990-04-05Manufacturing (CMC) · Supplement 9 · standardAP

1989-04-10Manufacturing (CMC) · Supplement 8 · standardAP

1986-12-11Labeling · Supplement 6 · standardAP

1986-12-11Manufacturing (CMC) · Supplement 7 · standardAP

1985-06-19Manufacturing (CMC) · Supplement 1 · standardAP

1984-07-27Manufacturing (CMC) · Supplement 5 · standardAP

1984-01-17Type 3 - New Dosage Form · 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.

Weekly Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.