Hydrocortisone

ANDA 40761, held by Strides Pharma Intl. Hydrocortisone.

As of Nov 13, 2026, ANDA 40761 (Hydrocortisone), held by Strides Pharma Intl, was first approved by FDA on Jul 16, 2007, with 3 approved supplements and 0 published complete response letters.

First approved: Jul 16, 2007
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
Jul 16, 2007	Original application	Approved	None posted

Products

3 strengths and forms


Hydrocortisone5MG · tablet;oral	Hydrocortisone	Discontinued
Hydrocortisone10MG · tablet;oral	Hydrocortisone	Discontinued
Hydrocortisone20MG · tablet;oral	Hydrocortisone	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Feb 3, 2025	Supplement 16Labeling · Standard review	Approved	None posted
Mar 28, 2024	Supplement 10Labeling · Standard review	Approved	None posted
Mar 28, 2024	Supplement 15Labeling · Standard review	Approved	None posted
Jul 16, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 40761
Drugs@FDA: Overview at FDA
Company: Strides Pharma International

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