Fosinopril Sodium

ANDA 76906, held by Apotex. Fosinopril Sodium.

As of Nov 15, 2026, ANDA 76906 (Fosinopril Sodium), held by Apotex, was first approved by FDA on May 17, 2005, with 3 approved supplements and 0 published complete response letters.

First approved: May 17, 2005
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
May 17, 2005	Original application	Approved	None posted

Products

3 strengths and forms


Fosinopril Sodium10MG · tablet;oral	Fosinopril Sodium	Discontinued
Fosinopril Sodium20MG · tablet;oral	Fosinopril Sodium	Discontinued
Fosinopril Sodium40MG · tablet;oral	Fosinopril Sodium	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Dec 31, 2013	Supplement 10Labeling · Standard review	Approved	None posted
Apr 8, 2011	Supplement 9Labeling	Approved	None posted
Oct 28, 2010	Supplement 8Labeling	Approved	None posted
May 17, 2005	Original application	Approved	None posted

Identifiers

Application: ANDA 76906
Drugs@FDA: Overview at FDA
Company: Apotex

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