← FDA DRUG APPROVALS

FDA NDA · NDA019018

TROPHAMINE

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

Sponsor: B BRAUN

APPLICATION
NDA019018
TYPE
NDA
ORIGINAL APPROVAL
1984-07-20
LATEST ACTION
2020-10-26
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

TROPHAMINE 10% · ReferencePrescription
AMINO ACIDS 10% (10GM/100ML) · INJECTABLE · INJECTION
TROPHAMINE · ReferencePrescription
AMINO ACIDS 6% (6GM/100ML) · INJECTABLE · INJECTION

Approval history

2020-10-26Manufacturing (CMC) · Supplement 36 — Letter ↗AP
2014-01-17Manufacturing (CMC) · Supplement 32 · standardAP
2013-11-08Manufacturing (CMC) · Supplement 31 · standardAP
2013-03-19Manufacturing (CMC) · Supplement 26 · standardAP
2004-03-24Manufacturing (CMC) · Supplement 18 · standard — Label ↗AP
2000-06-20Manufacturing (CMC) · Supplement 17 · standardAP
2000-04-11Manufacturing (CMC) · Supplement 16 · standardAP
1998-04-23Manufacturing (CMC) · Supplement 10 · standardAP
1996-06-14Manufacturing (CMC) · Supplement 15 · standardAP
1994-10-28Manufacturing (CMC) · Supplement 14 · standardAP
1992-09-28Manufacturing (CMC) · Supplement 13 · standardAP
1991-12-11Manufacturing (CMC) · Supplement 12 · standardAP
1990-04-11Manufacturing (CMC) · Supplement 11 · standardAP
1988-12-19Manufacturing (CMC) · Supplement 8 · standardAP
1988-09-07Labeling · Supplement 6AP
1988-09-07Manufacturing (CMC) · Supplement 5 · standardAP
1988-01-13Labeling · Supplement 4AP
1987-07-09Labeling · Supplement 3AP
1986-10-09Labeling · Supplement 2AP
1985-02-21Labeling · Supplement 1AP
1984-07-20Type 5 - New Formulation or New Manufacturer · Original · standardAP
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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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