APPLICATION
ANDA020360
TYPE
ANDA
ORIGINAL APPROVAL
1996-04-04
LATEST ACTION
2003-09-08
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
HEPATASOL 8%Discontinued
AMINO ACIDS 8% (8GM/100ML) · INJECTABLE · INJECTION
Approval history
2003-09-08Labeling · Supplement 8AP
2001-02-28Labeling · Supplement 4AP
2000-04-21Manufacturing (CMC) · Supplement 5 · standardAP
1999-06-11Manufacturing (CMC) · Supplement 3 · standardAP
1997-07-16Manufacturing (CMC) · Supplement 1 · standardAP
1996-09-13Manufacturing (CMC) · Supplement 2 · standardAP
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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