Prednisone

Controls severe or incapacitating allergic conditions. ANDA 213386, held by Amneal. Prednisone.

As of Nov 14, 2026, ANDA 213386 (Prednisone), held by Amneal, was first approved by FDA on Jun 24, 2020, with 1 approved supplement and 0 published complete response letters.

First approved: Jun 24, 2020
Review: Standard
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS 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 2 submissions below

Date	Submission	Status	Documents
Jun 24, 2020	Original application	Approved	None posted

Products

2 strengths and forms


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

All 2 submissions, including labeling and manufacturing supplements


Jun 5, 2024	Supplement 4Labeling · Standard review	Approved	None posted
Jun 24, 2020	Original application	Approved	None posted

Identifiers

Application: ANDA 213386
Drugs@FDA: Overview at FDA
Company: Amneal Pharmaceuticals

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