← FDA DRUG APPROVALS

FDA NDA · NDA208171

MONOFERRIC

ferric derisomaltose

Sponsor: PHARMACOSMOS

APPLICATION
NDA208171
TYPE
NDA
ORIGINAL APPROVAL
2020-01-16
LATEST ACTION
2024-08-01
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription, Discontinued

Products

MONOFERRIC · ReferencePrescription
FERRIC DERISOMALTOSE 1GM/10ML (100MG/ML) · SOLUTION · INTRAVENOUS
MONOFERRIC · ReferenceDiscontinued
FERRIC DERISOMALTOSE 100MG/ML (100MG/ML) · SOLUTION · INTRAVENOUS
MONOFERRIC · ReferenceDiscontinued
FERRIC DERISOMALTOSE 500MG/5ML (100MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2024-08-01Labeling · Supplement 3 · standard — Label ↗AP
2022-08-04Labeling · Supplement 2 · standard — Letter ↗AP
2020-09-11Labeling · Supplement 1 · standard — Letter ↗AP
2020-01-16Type 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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →