Hydrocortisone

ANDA 88082, held by Paddock LLC. Hydrocortisone.

As of Nov 14, 2026, ANDA 88082 (Hydrocortisone), held by Paddock LLC, was first approved by FDA on Apr 8, 1983, with 5 approved supplements and 0 published complete response letters.

First approved: Apr 8, 1983
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
Apr 8, 1983	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hydrocortisone100% · powder;for rx compounding	Hydrocortisone	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Jul 7, 1995	Supplement 6Manufacturing	Approved	None posted
Jun 21, 1995	Supplement 7Manufacturing	Approved	None posted
Apr 5, 1993	Supplement 5Manufacturing	Approved	None posted
Apr 5, 1993	Supplement 4Manufacturing	Approved	None posted
Apr 5, 1993	Supplement 2Manufacturing	Approved	None posted
Apr 8, 1983	Original application	Approved	None posted

Identifiers

Application: ANDA 88082
Drugs@FDA: Overview at FDA
Company: Paddock 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