Tamoxifen Citrate

ANDA 76027, held by Roxane. Tamoxifen Citrate.

As of Nov 15, 2026, ANDA 76027 (Tamoxifen Citrate), held by Roxane, was first approved by FDA on Feb 20, 2003, with 1 approved supplement and 0 published complete response letters.

First approved: Feb 20, 2003
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 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 2 submissions, including labeling and manufacturing supplements


Apr 4, 2007	Supplement 1Labeling	Approved	None posted
Feb 20, 2003	Original application	Approved	None posted

Identifiers

Application: ANDA 76027
Drugs@FDA: Overview at FDA
Company: Roxane 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