Prednisone

Controls severe or incapacitating allergic conditions. ANDA 213385, held by Amneal. Prednisone.

As of Nov 14, 2026, ANDA 213385 (Prednisone), held by Amneal, was first approved by FDA on Jun 16, 2020, with 1 approved supplement and 0 published complete response letters.

First approved: Jun 16, 2020
Review: Standard
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS 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 Nonsuppurative thyroiditis Hypercalcemia associated with cancer 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 16, 2020	Original application	Approved	None posted

Products

2 strengths and forms


Prednisone1MG · tablet;oral	Prednisone	Rx
Prednisone5MG · tablet;oral	Prednisone	Rx

All 2 submissions, including labeling and manufacturing supplements


Jun 5, 2024	Supplement 4Labeling · Standard review	Approved	None posted
Jun 16, 2020	Original application	Approved	None posted

Identifiers

Application: ANDA 213385
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