Taxol

NDA 20262, held by Hq Spclt Pharma. Paclitaxel.

As of Nov 14, 2026, NDA 20262 (Taxol), held by Hq Spclt Pharma, was first approved by FDA on Dec 29, 1992, with 43 approved supplements and 0 published complete response letters.

First approved: Dec 29, 1992
Review: Priority
Supplements approved: 43
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 44 submissions below


Jun 20, 2000	Supplement 36Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Oct 25, 1999	Supplement 33Efficacy (new indication or use) · Priority review	Approved	Label Letter
Jun 30, 1998	Supplement 24Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Apr 9, 1998	Supplement 26Efficacy (new indication or use) · Priority review	Approved	Review Label Letter
Aug 4, 1997	Supplement 22Efficacy (new indication or use) · Priority review	Approved	None posted
Jun 22, 1994	Supplement 3Efficacy (new indication or use) · Standard review	Approved	None posted
Apr 13, 1994	Supplement 4Efficacy (new indication or use) · Standard review	Approved	None posted
Dec 29, 1992	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Taxol6MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Paclitaxel	DiscontinuedReference drug

All 44 submissions, including labeling and manufacturing supplements


Mar 3, 2015	Supplement 51Labeling · Standard review	Approved	Label Letter
Jun 27, 2014	Supplement 50Manufacturing · Priority review	Approved	None posted
May 2, 2011	Supplement 49Labeling · Standard review	Approved	Letter Label
Aug 13, 2010	Supplement 48Labeling · Standard review	Approved	Review Letter Label
Mar 5, 2003	Supplement 41Labeling · Standard review	Approved	Letter
Dec 12, 2002	Supplement 42Manufacturing · Priority review	Approved	None posted
Aug 29, 2002	Supplement 35Labeling · Standard review	Approved	Letter
Mar 4, 2002	Supplement 38Labeling · Standard review	Approved	Review Letter
Mar 4, 2002	Supplement 37Labeling · Priority review	Approved	Review Letter
May 23, 2001	Supplement 40Manufacturing · Priority review	Approved	None posted
Apr 10, 2001	Supplement 39Manufacturing · Priority review	Approved	None posted
Jun 20, 2000	Supplement 36Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Dec 10, 1999	Supplement 32Labeling · Standard review	Approved	None posted
Oct 25, 1999	Supplement 33Efficacy (new indication or use) · Priority review	Approved	Label Letter
Mar 19, 1999	Supplement 30Manufacturing · Priority review	Approved	None posted
Jan 8, 1999	Supplement 31Labeling · Standard review	Approved	Review
Jan 8, 1999	Supplement 14Labeling · Standard review	Approved	Review
Jan 8, 1999	Supplement 16Labeling · Standard review	Approved	Review
Jan 8, 1999	Supplement 21Labeling · Standard review	Approved	Review
Nov 5, 1998	Supplement 29Manufacturing · Priority review	Approved	None posted
Jun 30, 1998	Supplement 24Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Apr 9, 1998	Supplement 28Labeling · Priority review	Approved	Review Label Letter
Apr 9, 1998	Supplement 27Labeling · Priority review	Approved	Review Letter Label
Apr 9, 1998	Supplement 26Efficacy (new indication or use) · Priority review	Approved	Review Label Letter
Apr 1, 1998	Supplement 23Manufacturing · Priority review	Approved	None posted
Dec 19, 1997	Supplement 25Manufacturing · Priority review	Approved	None posted
Sep 18, 1997	Supplement 18Manufacturing · Priority review	Approved	None posted
Aug 4, 1997	Supplement 22Efficacy (new indication or use) · Priority review	Approved	None posted
Apr 25, 1997	Supplement 19Manufacturing · Priority review	Approved	None posted
Mar 5, 1997	Supplement 17Manufacturing · Priority review	Approved	None posted
Dec 13, 1996	Supplement 15Manufacturing · Priority review	Approved	None posted
Apr 3, 1996	Supplement 13Manufacturing · Priority review	Approved	None posted
Apr 1, 1996	Supplement 12Labeling · Standard review	Approved	None posted
May 5, 1995	Supplement 11Manufacturing · Priority review	Approved	None posted
Feb 15, 1995	Supplement 10Manufacturing · Priority review	Approved	None posted
Oct 19, 1994	Supplement 8Manufacturing · Priority review	Approved	None posted
Jul 22, 1994	Supplement 9Manufacturing · Priority review	Approved	None posted
Jun 22, 1994	Supplement 3Efficacy (new indication or use) · Standard review	Approved	None posted
Apr 21, 1994	Supplement 7Manufacturing · Priority review	Approved	None posted
Apr 13, 1994	Supplement 4Efficacy (new indication or use) · Standard review	Approved	None posted
Mar 16, 1994	Supplement 5Manufacturing · Priority review	Approved	None posted
Jul 23, 1993	Supplement 2Labeling · Standard review	Approved	None posted
Jun 25, 1993	Supplement 1Manufacturing · Priority review	Approved	None posted
Dec 29, 1992	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 20262
Drugs@FDA: Overview at FDA
Company: HQ Specialty Pharma

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