Prednisone

ANDA 80514, held by Chartwell Molecular. Prednisone.

As of Nov 14, 2026, ANDA 80514 (Prednisone), held by Chartwell Molecular, was first approved by FDA on May 2, 1974, with 2 approved supplements and 0 published complete response letters.

First approved: May 2, 1974
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
May 2, 1974	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Prednisone5MG · tablet;oral	Prednisone	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Jun 7, 2024	Supplement 12Labeling · Standard review	Approved	None posted
Jun 7, 2024	Supplement 13Labeling · Standard review	Approved	None posted
May 2, 1974	Original application	Approved	None posted

Identifiers

Application: ANDA 80514
Drugs@FDA: Overview at FDA
Company: Chartwell Molecular

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