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FDA NDA · NDA210864

SESQUIENT

Sponsor: LUPIN

APPLICATION
NDA210864
TYPE
NDA
ORIGINAL APPROVAL
2020-11-05
LATEST ACTION
2020-11-05
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

SESQUIENT · ReferenceDiscontinued
FOSPHENYTOIN SODIUM EQ 100MG PHENYTOIN NA/2ML (EQ 50MG PHENYTOIN NA/ML) · SOLUTION · INTRAVENOUS
SESQUIENT · ReferenceDiscontinued
FOSPHENYTOIN SODIUM EQ 500MG PHENYTOIN NA/10ML (EQ 50MG PHENYTOIN NA/ML) · SOLUTION · INTRAVENOUS

Approval history

2020-11-05Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗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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