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FDA NDA · NDA208010

RAYALDEE

calcifediol

Sponsor: EIRGEN

APPLICATION
NDA208010
TYPE
NDA
ORIGINAL APPROVAL
2016-06-17
LATEST ACTION
2024-01-19
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

RAYALDEE · ReferencePrescription
CALCIFEDIOL 0.03MG · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2024-01-19Manufacturing (CMC) · Supplement 13 — Label ↗AP
2019-12-17Labeling · Supplement 5 · standard — Label ↗AP
2016-12-14Manufacturing (CMC) · Supplement 1 · standardAP
2016-06-17Type 5 - New Formulation or New Manufacturer · 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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