APPLICATION
ANDA020345
TYPE
ANDA
ORIGINAL APPROVAL
1996-04-04
LATEST ACTION
2005-09-15
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
AMINOSYN-HF 8%Discontinued
AMINO ACIDS 8% (8GM/100ML) · INJECTABLE · INJECTION
Approval history
2005-09-15Labeling · Supplement 8AP
1998-04-01Manufacturing (CMC) · Supplement 2 · standardAP
1997-07-29Manufacturing (CMC) · Supplement 3 · standardAP
1997-07-14Labeling · Supplement 1AP
1996-04-04Type 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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