Prednisolone

ANDA 40192, held by We Pharms. Prednisolone.

As of Nov 15, 2026, ANDA 40192 (Prednisolone), held by We Pharms, was first approved by FDA on May 28, 1998, with 5 approved supplements and 0 published complete response letters.

First approved: May 28, 1998
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
May 28, 1998	Original application	Approved	Letter Review

Products

1 strengths and forms

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

All 6 submissions, including labeling and manufacturing supplements


Sep 16, 2002	Supplement 8Labeling	Approved	None posted
Apr 12, 2002	Supplement 7Manufacturing	Approved	None posted
Aug 28, 2000	Supplement 2Manufacturing	Approved	None posted
Aug 28, 2000	Supplement 3Manufacturing	Approved	None posted
Jul 16, 1998	Supplement 1Labeling	Approved	None posted
May 28, 1998	Original application	Approved	Letter Review

Identifiers

Application: ANDA 40192
Drugs@FDA: Overview at FDA
Company: We Pharms

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