NDA 21743, held by Osi Pharms. Erlotinib Hydrochloride.
As of Nov 15, 2026, NDA 21743 (Tarceva), held by Osi Pharms, was first approved by FDA on Nov 18, 2004, with 18 approved supplements and 0 published complete response letters.
| Oct 18, 2016 | Supplement 25Efficacy (new indication or use) · Standard review | Approved | |
| Jun 1, 2016 | Supplement 27Efficacy (new indication or use) · Standard review | Approved | |
| May 20, 2016 | Supplement 23Efficacy (new indication or use) · Standard review | Approved | |
| Apr 27, 2015 | Supplement 21Efficacy (new indication or use) · Priority review | Approved | |
| May 14, 2013 | Supplement 18Efficacy (new indication or use) · Priority review | Approved | |
| Apr 16, 2010 | Supplement 16Efficacy (new indication or use) · Standard review | Approved | |
| Sep 19, 2008 | Supplement 11Efficacy (new indication or use) | Approved | |
| Nov 2, 2005 | Supplement 3Efficacy (new indication or use) · Priority review | Approved | |
| Nov 18, 2004 | Original applicationNew molecular entity · Priority review | Approved |
| TarcevaEQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Erlotinib Hydrochloride | DiscontinuedReference drug |
| TarcevaEQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Erlotinib Hydrochloride | DiscontinuedReference drug |
| TarcevaEQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Erlotinib Hydrochloride | DiscontinuedReference drug |
| Oct 18, 2016 | Supplement 25Efficacy (new indication or use) · Standard review | Approved | |
| Sep 28, 2016 | Supplement 26Labeling · Standard review | Approved | |
| Jun 1, 2016 | Supplement 27Efficacy (new indication or use) · Standard review | Approved | |
| May 20, 2016 | Supplement 23Efficacy (new indication or use) · Standard review | Approved | |
| Mar 15, 2016 | Supplement 24Manufacturing · Priority review | Approved | None posted |
| Jul 6, 2015 | Supplement 22Manufacturing · Priority review | Approved | None posted |
| Apr 27, 2015 | Supplement 21Efficacy (new indication or use) · Priority review | Approved | |
| Apr 14, 2014 | Supplement 19Labeling · Standard review | Approved | |
| May 14, 2013 | Supplement 18Efficacy (new indication or use) · Priority review | Approved | |
| Apr 17, 2012 | Supplement 17Labeling | Approved | |
| Apr 16, 2010 | Supplement 16Efficacy (new indication or use) · Standard review | Approved | |
| Apr 16, 2010 | Supplement 14Labeling · Standard review | Approved | |
| Apr 27, 2009 | Supplement 15Labeling · Standard review | Approved | |
| Sep 19, 2008 | Supplement 11Efficacy (new indication or use) | Approved | |
| Sep 12, 2008 | Supplement 10Labeling · Standard review | Approved | |
| Sep 12, 2008 | Supplement 8Labeling · Priority review | Approved | |
| Apr 27, 2007 | Supplement 7Labeling · Standard review | Approved | |
| Nov 2, 2005 | Supplement 3Efficacy (new indication or use) · Priority review | Approved | |
| Nov 18, 2004 | Original applicationNew molecular entity · Priority review | Approved |
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
