FDA NDA · NDA019374

AMINOSYN-HBC 7%

Sponsor: ICU MEDICAL INC

APPLICATION

NDA019374

TYPE

NDA

ORIGINAL APPROVAL

1985-07-12

LATEST ACTION

2002-10-25

ROUTE

INJECTION

DOSAGE FORM

INJECTABLE

MARKETING STATUS

Discontinued

Products

AMINOSYN-HBC 7%Discontinued

AMINO ACIDS 7% (7GM/100ML) · INJECTABLE · INJECTION

2002-10-25Manufacturing (CMC) · Supplement 15 · standard — Letter ↗AP

1999-11-03Labeling · Supplement 14 · standardAP

1999-01-22Manufacturing (CMC) · Supplement 13 · standardAP

1997-05-05Manufacturing (CMC) · Supplement 12 · standardAP

1996-08-27Manufacturing (CMC) · Supplement 11 · standardAP

1994-07-11Manufacturing (CMC) · Supplement 10 · standardAP

1993-12-30Manufacturing (CMC) · Supplement 9 · standardAP

1992-08-18Manufacturing (CMC) · Supplement 8 · standardAP

1992-02-10Manufacturing (CMC) · Supplement 7 · standardAP

1987-10-21Labeling · Supplement 6AP

1986-04-01Manufacturing (CMC) · Supplement 1 · standardAP

1986-01-31Manufacturing (CMC) · Supplement 2 · standardAP

1985-07-12Manufacturing (CMC) · Supplement 3 · standardAP

1985-07-12Type 5 - New Formulation or New Manufacturer · Original · standardAP

1985-07-12Manufacturing (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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