Orapred Odt

NDA 21959, held by Advanz Pharma. Prednisolone Sodium Phosphate.

As of Nov 14, 2026, NDA 21959 (Orapred Odt), held by Advanz Pharma, was first approved by FDA on Jun 1, 2006, with 6 approved supplements and 0 published complete response letters.

First approved: Jun 1, 2006
Review: Standard
Supplements approved: 6
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Orapred ODT (prednisolone sodium phosphate orally disintegrating tablet) is indicated in the treatment of the following diseases or conditions: Orapred ODT is a corticosteroid indicated as an anti-inflammatory or immunosuppressive agent for certain allergic, dermatologic, gastrointestinal, hematologic, ophthalmologic, nervous system, renal, respiratory, rheumatologic, specific infectious diseases or conditions and organ transplantation for the treatment of certain endocrine conditions for palliation of certain neoplastic conditions 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Jun 1, 2006	Original applicationNew dosage form · Standard review	Approved	Review Label

Products

3 strengths and forms


Orapred OdtEQ 10MG BASE · tablet, orally disintegrating;oral	Prednisolone Sodium Phosphate	RxReference drug
Orapred OdtEQ 15MG BASE · tablet, orally disintegrating;oral	Prednisolone Sodium Phosphate	RxReference drug
Orapred OdtEQ 30MG BASE · tablet, orally disintegrating;oral	Prednisolone Sodium Phosphate	RxReference drug

All 7 submissions, including labeling and manufacturing supplements


Jun 5, 2024	Supplement 14Labeling · Standard review	Approved	Letter Label
Mar 6, 2020	Supplement 11Labeling · Standard review	Approved	Letter Label
Jul 28, 2016	Supplement 9Manufacturing · Standard review	Approved	None posted
Apr 8, 2016	Supplement 8Manufacturing · Standard review	Approved	None posted
Jul 28, 2010	Supplement 4Labeling · Standard review	Approved	Label Letter
Apr 27, 2009	Supplement 3Manufacturing	Approved	Label Letter
Jun 1, 2006	Original applicationNew dosage form · Standard review	Approved	Review Label

Identifiers

Application: NDA 21959
Drugs@FDA: Overview at FDA
Company: ADVANZ PHARMA

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters