Prednisolone

ANDA 80354, held by Watson Labs. Prednisolone.

As of Nov 15, 2026, ANDA 80354 (Prednisolone), held by Watson Labs, was first approved by FDA on Jan 17, 1972, with 12 approved supplements and 0 published complete response letters.

First approved: Jan 17, 1972
Supplements approved: 12
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Jan 17, 1972	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Prednisolone5MG · tablet;oral	Prednisolone	RxReference drug

All 13 submissions, including labeling and manufacturing supplements


Jun 5, 2024	Supplement 72Labeling · Standard review	Approved	None posted
Sep 16, 2007	Supplement 54Manufacturing	Approved	None posted
Dec 4, 2001	Supplement 48Manufacturing	Approved	None posted
Apr 25, 2001	Supplement 46Manufacturing	Approved	None posted
Dec 30, 1998	Supplement 44Manufacturing	Approved	None posted
Mar 30, 1994	Supplement 43Labeling	Approved	None posted
Mar 26, 1991	Supplement 42Labeling	Approved	None posted
Jan 28, 1991	Supplement 41Manufacturing	Approved	None posted
Jun 3, 1985	Supplement 33Manufacturing	Approved	None posted
Jun 3, 1985	Supplement 34Manufacturing	Approved	None posted
Dec 27, 1983	Supplement 31Manufacturing	Approved	None posted
Nov 22, 1983	Supplement 30Manufacturing	Approved	None posted
Jan 17, 1972	Original application	Approved	None posted

Identifiers

Application: ANDA 80354
Drugs@FDA: Overview at FDA
Company: Watson Laboratories

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