Prednisolone

ANDA 40313, held by Pharmobedient Cnsltg. Prednisolone.

As of Nov 15, 2026, ANDA 40313 (Prednisolone), held by Pharmobedient Cnsltg, was first approved by FDA on Sep 10, 2003, with 3 approved supplements and 0 published complete response letters.

First approved: Sep 10, 2003
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Sep 10, 2003	Original application	Approved	None posted

Products

1 strengths and forms

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

All 4 submissions, including labeling and manufacturing supplements


Jul 22, 2024	Supplement 4Labeling · Standard review	Approved	None posted
Apr 14, 2005	Supplement 2Labeling	Approved	None posted
Feb 20, 2004	Supplement 1Labeling	Approved	None posted
Sep 10, 2003	Original application	Approved	None posted

Identifiers

Application: ANDA 40313
Drugs@FDA: Overview at FDA
Company: Pharmobedient Cnsltg

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