Application 020766

Type: NDA
Sponsor: CHEPLAPHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	XENICAL	ORLISTAT	CAPSULE;ORAL	120MG	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0004-0257	Xenical	orlistat	Genentech, Inc.	NDA	Current
61269-460	Xenical	orlistat	H2-Pharma LLC	NDA	Current
61269-460	Xenical	orlistat	H2-Pharma LLC	NDA	Current
61269-460	Xenical	orlistat	H2-Pharma LLC	NDA	Current
61269-460	Xenical	orlistat	H2-Pharma LLC	NDA	Current
61269-460	Xenical	orlistat	H2-Pharma LLC	NDA	Current
61269-565	ORLISTAT	orlistat	H2-Pharma LLC	NDA AUTHORIZED GENERIC	Current
61269-565	ORLISTAT	orlistat	H2-Pharma LLC	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
72655	SUPPL	2022-11-18
72652	SUPPL	2022-11-18
45070	SUPPL	2016-08-15
3300	SUPPL	2015-08-11
35309	SUPPL	2015-08-10
25753	SUPPL	2013-10-18
13385	SUPPL	2013-10-18
3299	SUPPL	2012-01-25
13384	SUPPL	2012-01-24
35308	SUPPL	2010-12-22
25752	SUPPL	2010-12-22
13383	SUPPL	2010-05-25
3298	SUPPL	2010-05-25
3297	SUPPL	2009-02-18
13382	SUPPL	2009-02-12
41681	SUPPL	2007-07-06
41680	SUPPL	2007-07-06
20925	SUPPL	2007-07-06
20924	SUPPL	2007-07-06
20923	SUPPL	2007-07-06
25751	SUPPL	2007-01-12
13381	SUPPL	2007-01-08
35307	SUPPL	2005-09-08
25750	SUPPL	2005-09-08
13379	SUPPL	2004-11-01
25748	SUPPL	2004-10-29
25749	SUPPL	2004-07-14
13380	SUPPL	2004-07-14
35306	SUPPL	2003-12-29
3296	SUPPL	2003-12-19
13378	SUPPL	2001-04-23
41679	ORIG	1999-08-13
25747	ORIG	1999-04-26
13377	ORIG	1999-04-26
52145	SUPPL	1900-01-01
52144	SUPPL	1900-01-01
52143	SUPPL	1900-01-01
52142	SUPPL	1900-01-01