Prednisolone

ANDA 40399, held by Pharm Assoc. Prednisolone.

As of Nov 15, 2026, ANDA 40399 (Prednisolone), held by Pharm Assoc, was first approved by FDA on Mar 5, 2003, with 2 approved supplements and 0 published complete response letters.

First approved: Mar 5, 2003
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
Mar 5, 2003	Original application	Approved	None posted

Products

1 strengths and forms

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

All 3 submissions, including labeling and manufacturing supplements


Jun 5, 2024	Supplement 4Labeling · Standard review	Approved	None posted
Sep 14, 2007	Supplement 3Labeling	Approved	None posted
Mar 5, 2003	Original application	Approved	None posted

Identifiers

Application: ANDA 40399
Drugs@FDA: Overview at FDA
Company: Pharmaceutical Associates

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