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AMINOSYN-PF 10%

NDA · New Drug Application · Sponsor: OTSUKA ICU MEDCL · Approved 1986-10-17

Drug application

FDA Application #

NDA019492

Application type

New Drug Application

Brand name

AMINOSYN-PF 10%

Generic name

ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, GLYCINE, HISTIDINE, PROLINE, SERINE, TAURINE, AND TYROSINE

Active ingredients

AMINO ACIDS

Dosage form

INJECTABLE

Route

INJECTION

Marketing status

Prescription

Sponsor

OTSUKA ICU MEDCL

Manufacturer

ICU Medical Inc.

First approval

1986-10-17

Source

Authoritative

Drugs@FDA application overview

Machine

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