Prednisolone

ANDA 40322, held by Teva Pharms. Prednisolone.

As of Nov 15, 2026, ANDA 40322 (Prednisolone), held by Teva Pharms, was first approved by FDA on Jan 19, 2000, with 1 approved supplement and 0 published complete response letters.

First approved: Jan 19, 2000
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
Jan 19, 2000	Original application	Approved	Letter Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Prednisolone15MG/5ML · solution;oral	Prednisolone	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Jun 5, 2024	Supplement 3Labeling · Standard review	Approved	None posted
Jan 19, 2000	Original application	Approved	Letter Review

Identifiers

Application: ANDA 40322
Drugs@FDA: Overview at FDA
Company: Teva 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