← FDA DRUG APPROVALS

FDA NDA · NDA021959

ORAPRED ODT

prednisolone sodium phosphate

Sponsor: ADVANZ PHARMA

APPLICATION
NDA021959
TYPE
NDA
ORIGINAL APPROVAL
2006-06-01
LATEST ACTION
2024-06-05
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Prescription

Products

ORAPRED ODT · ReferencePrescription
PREDNISOLONE SODIUM PHOSPHATE EQ 15MG BASE · TABLET, ORALLY DISINTEGRATING · ORAL
ORAPRED ODT · ReferencePrescription
PREDNISOLONE SODIUM PHOSPHATE EQ 30MG BASE · TABLET, ORALLY DISINTEGRATING · ORAL
ORAPRED ODT · ReferencePrescription
PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE · TABLET, ORALLY DISINTEGRATING · ORAL

Approval history

2024-06-05Labeling · Supplement 14 · standard — Label ↗AP
2020-03-06Labeling · Supplement 11 · standard — Label ↗AP
2016-07-28Manufacturing (CMC) · Supplement 9 · standardAP
2016-04-08Manufacturing (CMC) · Supplement 8 · standardAP
2010-07-28Labeling · Supplement 4 · standard — Label ↗AP
2009-04-27Manufacturing (CMC) · Supplement 3 — Letter ↗AP
2006-06-01Type 3 - New Dosage Form · 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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