Emtriva

NDA 21500, held by Gilead. Emtricitabine.

First approved: Jul 2, 2003
Review: Standard
Supplements approved: 12
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
May 16, 2008	Supplement 11Efficacy (new indication or use)	Approved	Letter
Jul 2, 2003	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Emtriva200MG · capsule;oral	Emtricitabine	Rx · reference drug

All 13 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Dec 10, 2018	Supplement 29Labeling · Standard review	Approved	Label Letter
Apr 7, 2017	Supplement 28Labeling · Standard review	Approved	Label
Mar 25, 2014	Supplement 25Manufacturing · Standard review	Approved	None posted
Nov 8, 2013	Supplement 24Manufacturing · Standard review	Approved	None posted
Apr 2, 2013	Supplement 21Labeling · Standard review	Approved	Label Letter
Jul 23, 2012	Supplement 19Labeling · Standard review	Approved	Letter Label
Nov 18, 2011	Supplement 18Labeling	Approved	Label Letter
May 16, 2008	Supplement 11Efficacy (new indication or use)	Approved	Letter
Apr 4, 2008	Supplement 10Labeling · Standard review	Approved	Label Letter
Dec 22, 2006	Supplement 7Labeling · Standard review	Approved	Letter Label
Dec 2, 2005	Supplement 3Labeling · Standard review	Approved	Letter Label
Jun 13, 2005	Supplement 2Labeling · Standard review	Approved	Letter
Jul 2, 2003	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21500
Drugs@FDA: Overview at FDA
Company: Gilead Sciences

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters