← FDA DRUG APPROVALS

FDA NDA · NDA019438

AMINOSYN II 10%

Sponsor: ICU MEDICAL INC

APPLICATION
NDA019438
TYPE
NDA
ORIGINAL APPROVAL
1986-04-03
LATEST ACTION
2003-06-06
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

AMINOSYN II 10%Discontinued
AMINO ACIDS 10% (10GM/100ML) · INJECTABLE · INJECTION
AMINOSYN II 7%Discontinued
AMINO ACIDS 7% (7GM/100ML) · INJECTABLE · INJECTION
AMINOSYN II 3.5%Discontinued
AMINO ACIDS 3.5% (3.5GM/100ML) · INJECTABLE · INJECTION
AMINOSYN II 8.5%Discontinued
AMINO ACIDS 8.5% (8.5GM/100ML) · INJECTABLE · INJECTION
AMINOSYN II 5%Discontinued
AMINO ACIDS 5% (5GM/100ML) · INJECTABLE · INJECTION

Approval history

2003-06-06Labeling · Supplement 13 · standardAP
2002-10-25Manufacturing (CMC) · Supplement 14 · standard — Letter ↗AP
1999-01-22Manufacturing (CMC) · Supplement 12 · standardAP
1997-05-05Manufacturing (CMC) · Supplement 11 · standardAP
1996-08-27Manufacturing (CMC) · Supplement 10 · standardAP
1994-07-11Manufacturing (CMC) · Supplement 9 · standardAP
1993-12-30Manufacturing (CMC) · Supplement 8 · standardAP
1992-09-28Manufacturing (CMC) · Supplement 7 · standardAP
1992-08-18Manufacturing (CMC) · Supplement 6 · standardAP
1992-02-10Manufacturing (CMC) · Supplement 4 · standardAP
1988-12-30Labeling · Supplement 5AP
1987-12-01Manufacturing (CMC) · Supplement 2 · standardAP
1987-06-29Labeling · Supplement 3AP
1986-04-03Type 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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