← FDA DRUG APPROVALS

FDA ANDA · ANDA091112

PLENAMINE

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

Sponsor: B BRAUN

APPLICATION
ANDA091112
TYPE
ANDA
ORIGINAL APPROVAL
2012-04-13
LATEST ACTION
2015-01-25
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

AMINO ACIDSPrescription
AMINO ACIDS 15%(150GM/1000ML) · INJECTABLE · INJECTION
AMINO ACIDSPrescription
AMINO ACIDS 15%(300GM/2000ML) · INJECTABLE · INJECTION

Approval history

2015-01-25Labeling · Supplement 2 · standardAP
2012-04-13OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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