Prednisone

Controls severe or incapacitating allergic conditions. ANDA 212629, held by Pharmazone. Prednisone.

As of Nov 14, 2026, ANDA 212629 (Prednisone), held by Pharmazone, was first approved by FDA on Dec 5, 2023, with 3 approved supplements and 0 published complete response letters.

First approved: Dec 5, 2023
Review: Standard
Supplements approved: 3
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 4 submissions below

Date	Submission	Status	Documents
Dec 5, 2023	Original application	Approved	None posted

Products

3 strengths and forms


Prednisone5MG · tablet;oral	Prednisone	Rx
Prednisone10MG · tablet;oral	Prednisone	Rx
Prednisone20MG · tablet;oral	Prednisone	Rx

All 4 submissions, including labeling and manufacturing supplements


Jun 7, 2024	Supplement 1Labeling · Standard review	Approved	None posted
Dec 5, 2023	Original application	Approved	None posted
Dec 5, 2023	Supplement 2	Approved	None posted
Dec 5, 2023	Supplement 3	Approved	None posted

Identifiers

Application: ANDA 212629
Drugs@FDA: Overview at FDA
Company: Pharmazone

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