Prednisone

ANDA 210525, held by Quagen. Prednisone.

As of Nov 15, 2026, ANDA 210525 (Prednisone), held by Quagen, was first approved by FDA on Dec 4, 2018, with 1 approved supplement and 0 published complete response letters.

First approved: Dec 4, 2018
Review: Standard
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Dec 4, 2018	Original application	Approved	None posted

Products

5 strengths and forms


Prednisone10MG · tablet;oral	Prednisone	Discontinued
Prednisone20MG · tablet;oral	Prednisone	Discontinued
Prednisone50MG · tablet;oral	Prednisone	Discontinued
Prednisone2.5MG · tablet;oral	Prednisone	Discontinued
Prednisone5MG · tablet;oral	Prednisone	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Jun 5, 2024	Supplement 6Labeling · Standard review	Approved	None posted
Dec 4, 2018	Original application	Approved	None posted

Identifiers

Application: ANDA 210525
Drugs@FDA: Overview at FDA
Company: Quagen 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