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FDA NDA · NDA208723

LEVOLEUCOVORIN CALCIUM

Sponsor: ACTAVIS LLC

APPLICATION
NDA208723
TYPE
NDA
ORIGINAL APPROVAL
2016-09-29
LATEST ACTION
2017-03-23
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Discontinued

Products

LEVOLEUCOVORIN CALCIUM · ReferenceDiscontinued
LEVOLEUCOVORIN CALCIUM EQ 175MG BASE/VIAL · POWDER · INTRAVENOUS

Approval history

2017-03-23Labeling · Supplement 2 · standard — Letter ↗AP
2016-09-29Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗AP
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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