← FDA DRUG APPROVALS

FDA NDA · NDA020015

AMINOSYN II

isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, aspartic acid, glutamic acid, histidine, proline, serine, n-acetyltyrosine, and glycine

Sponsor: OTSUKA ICU MEDCL

APPLICATION
NDA020015
TYPE
NDA
ORIGINAL APPROVAL
1991-12-19
LATEST ACTION
2014-09-15
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

AMINOSYN II 10% IN PLASTIC CONTAINERPrescription
AMINO ACIDS 10% (10GM/100ML) · INJECTABLE · INJECTION

Approval history

2014-09-15Manufacturing (CMC) · Supplement 33 · standardAP
2011-09-28Manufacturing (CMC) · Supplement 28AP
2003-06-30Labeling · Supplement 12AP
2003-05-13Labeling · Supplement 13AP
2002-11-01Manufacturing (CMC) · Supplement 10 · standardAP
1997-05-05Manufacturing (CMC) · Supplement 9 · standardAP
1997-03-04Manufacturing (CMC) · Supplement 8 · standardAP
1996-08-27Manufacturing (CMC) · Supplement 6 · standardAP
1995-11-09Manufacturing (CMC) · Supplement 3 · standardAP
1995-08-14Manufacturing (CMC) · Supplement 7 · standardAP
1995-04-05Manufacturing (CMC) · Supplement 2 · standardAP
1994-07-11Manufacturing (CMC) · Supplement 4 · standardAP
1992-08-17Labeling · Supplement 1AP
1991-12-19Type 5 - New Formulation or New Manufacturer · Original · standardAP
VIEW ON DRUGS@FDA ↗

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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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