← FDA DRUG APPROVALS

FDA NDA · NDA019492

AMINOSYN-PF

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

Sponsor: OTSUKA ICU MEDCL

APPLICATION
NDA019492
TYPE
NDA
ORIGINAL APPROVAL
1986-10-17
LATEST ACTION
2002-10-25
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

AMINOSYN-PF 10%Prescription
AMINO ACIDS 10% (10GM/100ML) · INJECTABLE · INJECTION

Approval history

2002-10-25Manufacturing (CMC) · Supplement 16 · standard — Letter ↗AP
2002-09-11Manufacturing (CMC) · Supplement 15 · standardAP
1999-06-08Manufacturing (CMC) · Supplement 14 · standardAP
1997-05-05Manufacturing (CMC) · Supplement 13 · standardAP
1996-08-27Manufacturing (CMC) · Supplement 12 · standardAP
1994-07-11Manufacturing (CMC) · Supplement 11 · standardAP
1993-12-30Manufacturing (CMC) · Supplement 10 · standardAP
1992-09-28Manufacturing (CMC) · Supplement 9 · standardAP
1992-08-18Manufacturing (CMC) · Supplement 7 · standardAP
1992-02-10Manufacturing (CMC) · Supplement 6 · standardAP
1990-12-21Manufacturing (CMC) · Supplement 8 · standardAP
1987-12-01Manufacturing (CMC) · Supplement 3 · standardAP
1987-11-24Manufacturing (CMC) · Supplement 1 · standardAP
1987-11-24Labeling · Supplement 2AP
1987-10-20Labeling · Supplement 4AP
1986-10-17Type 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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