Tamoxifen Citrate

ANDA 75740, held by Ivax Sub Teva Pharms. Tamoxifen Citrate.

As of Nov 15, 2026, ANDA 75740 (Tamoxifen Citrate), held by Ivax Sub Teva Pharms, was first approved by FDA on Feb 20, 2003, with 3 approved supplements and 0 published complete response letters.

First approved: Feb 20, 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
Feb 20, 2003	Original application	Approved	None posted

Products

2 strengths and forms


Tamoxifen CitrateEQ 10MG BASE · tablet;oral	Tamoxifen Citrate	Discontinued
Tamoxifen CitrateEQ 20MG BASE · tablet;oral	Tamoxifen Citrate	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Aug 1, 2005	Supplement 7Labeling	Approved	None posted
Jan 31, 2005	Supplement 6Labeling	Approved	None posted
Aug 11, 2003	Supplement 3Labeling	Approved	None posted
Feb 20, 2003	Original application	Approved	None posted

Identifiers

Application: ANDA 75740
Drugs@FDA: Overview at FDA
Company: IVAX Pharmaceuticals

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