Prednisone

Controls severe or incapacitating allergic conditions. ANDA 40256, held by Ph Health. Prednisone.

As of Nov 14, 2026, ANDA 40256 (Prednisone), held by Ph Health, was first approved by FDA on Jul 12, 2002, with 5 approved supplements and 0 published complete response letters.

First approved: Jul 12, 2002
Supplements approved: 5
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE PredniSONE Tablets are indicated in the following conditions: 1. Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance) Congenital adrenal hyperplasia Hypercalcemia associated with cancer Nonsuppurative thyroiditis 2.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Jul 12, 2002	Original application	Approved	Letter

Products

2 strengths and forms


Prednisone5MG · tablet;oral	Prednisone	Rx
Prednisone10MG · tablet;oral	Prednisone	Rx

All 6 submissions, including labeling and manufacturing supplements


Jun 5, 2024	Supplement 24Labeling · Standard review	Approved	None posted
May 28, 2024	Supplement 17Labeling · Standard review	Approved	None posted
May 28, 2024	Supplement 9Labeling	Approved	None posted
Jan 16, 2008	Supplement 4Labeling	Approved	None posted
Nov 20, 2003	Supplement 2Labeling	Approved	None posted
Jul 12, 2002	Original application	Approved	Letter

Identifiers

Application: ANDA 40256
Drugs@FDA: Overview at FDA
Company: PH Health

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