← FDA DRUG APPROVALS

FDA ANDA · ANDA075880

PREMASOL - SULFITE-FREE (AMINO ACID)

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

Sponsor: BAXTER HLTHCARE

APPLICATION
ANDA075880
TYPE
ANDA
ORIGINAL APPROVAL
2003-06-19
LATEST ACTION
2006-02-06
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

PREMASOL 10% IN PLASTIC CONTAINERPrescription
AMINO ACIDS 10% (10GM/100ML) · INJECTABLE · INJECTION
PREMASOL 6% IN PLASTIC CONTAINERPrescription
AMINO ACIDS 6% (6GM/100ML) · INJECTABLE · INJECTION

Approval history

2006-02-06Labeling · Supplement 6AP
2004-08-23Labeling · Supplement 1AP
2003-06-19OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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