← FDA DRUG APPROVALS

FDA NDA · NDA020041

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
NDA020041
TYPE
NDA
ORIGINAL APPROVAL
1991-12-19
LATEST ACTION
2007-04-27
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

AMINOSYN II 15% IN PLASTIC CONTAINERPrescription
AMINO ACIDS 15% (15GM/100ML) · INJECTABLE · INJECTION

Approval history

2007-04-27Manufacturing (CMC) · Supplement 20AP
2003-01-27Manufacturing (CMC) · Supplement 13 · standard — Letter ↗AP
2002-11-08Manufacturing (CMC) · Supplement 12 · standardAP
2002-08-21Labeling · Supplement 11 · standard — Letter ↗AP
1997-05-05Manufacturing (CMC) · Supplement 10 · standardAP
1997-03-04Manufacturing (CMC) · Supplement 8 · standardAP
1996-08-27Manufacturing (CMC) · Supplement 6 · standardAP
1996-08-06Manufacturing (CMC) · Supplement 9 · 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 3 - New Dosage Form · 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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