← FDA DRUG APPROVALS

FDA NDA · NDA212320

ACCRUFER

ferric maltol

Sponsor: SHIELD TX

APPLICATION
NDA212320
TYPE
NDA
ORIGINAL APPROVAL
2019-07-25
LATEST ACTION
2025-12-19
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

ACCRUFER · ReferencePrescription
FERRIC MALTOL 30MG IRON · CAPSULE · ORAL

Approval history

2025-12-19Efficacy · Supplement 19 · priority — Label ↗AP
2022-09-08Labeling · Supplement 15 · standard — Letter ↗AP
2022-06-01Labeling · Supplement 13 · standard — Letter ↗AP
2022-02-16Labeling · Supplement 11 · standard — Letter ↗AP
2020-10-28Labeling · Supplement 5 · standard — Label ↗AP
2019-07-25Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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