Application 019766

Type: NDA
Sponsor: MSD MERCK CO

Related Records

Company: MSD MERCK CO

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZOCOR	SIMVASTATIN	TABLET;ORAL	5MG	Yes	No
002	ZOCOR	SIMVASTATIN	TABLET;ORAL	10MG	Yes	No
003	ZOCOR	SIMVASTATIN	TABLET;ORAL	20MG	Yes	No
004	ZOCOR	SIMVASTATIN	TABLET;ORAL	40MG	Yes	No
005	ZOCOR	SIMVASTATIN	TABLET;ORAL	80MG	Yes	Yes

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0006-0543	ZOCOR	SIMVASTATIN	Merck Sharp & Dohme Corp.	NDA	Current
0006-0543	ZOCOR	SIMVASTATIN	Merck Sharp & Dohme Corp.	NDA	Current
0006-0543	ZOCOR	SIMVASTATIN	Merck Sharp & Dohme Corp.	NDA	Current
0006-0543	ZOCOR	SIMVASTATIN	Merck Sharp & Dohme Corp.	NDA	Current
0006-0543	ZOCOR	SIMVASTATIN	Merck Sharp & Dohme Corp.	NDA	Current
0006-0726	ZOCOR	SIMVASTATIN	Merck Sharp & Dohme Corp.	NDA	Current
0006-0735	ZOCOR	SIMVASTATIN	Merck Sharp & Dohme Corp.	NDA	Current
0006-0735	ZOCOR	SIMVASTATIN	Merck Sharp & Dohme Corp.	NDA	Current
0006-0735	ZOCOR	SIMVASTATIN	Merck Sharp & Dohme Corp.	NDA	Current
0006-0735	ZOCOR	SIMVASTATIN	Merck Sharp & Dohme Corp.	NDA	Current
0006-0735	ZOCOR	SIMVASTATIN	Merck Sharp & Dohme Corp.	NDA	Current
0006-0740	ZOCOR	SIMVASTATIN	Merck Sharp & Dohme Corp.	NDA	Current
0006-0740	ZOCOR	SIMVASTATIN	Merck Sharp & Dohme Corp.	NDA	Current
0006-0740	ZOCOR	SIMVASTATIN	Merck Sharp & Dohme Corp.	NDA	Current
0006-0740	ZOCOR	SIMVASTATIN	Merck Sharp & Dohme Corp.	NDA	Current
0006-0740	ZOCOR	SIMVASTATIN	Merck Sharp & Dohme Corp.	NDA	Current
0006-0749	ZOCOR	SIMVASTATIN	Merck Sharp & Dohme Corp.	NDA	Current
0006-0749	ZOCOR	SIMVASTATIN	Merck Sharp & Dohme Corp.	NDA	Current
0006-0749	ZOCOR	SIMVASTATIN	Merck Sharp & Dohme Corp.	NDA	Current
0006-0749	ZOCOR	SIMVASTATIN	Merck Sharp & Dohme Corp.	NDA	Current
0006-0749	ZOCOR	SIMVASTATIN	Merck Sharp & Dohme Corp.	NDA	Current
78206-179	ZOCOR	SIMVASTATIN	Organon LLC	NDA	Current
78206-179	ZOCOR	SIMVASTATIN	Organon LLC	NDA	Current
78206-179	ZOCOR	SIMVASTATIN	Organon LLC	NDA	Current
78206-180	ZOCOR	SIMVASTATIN	Organon LLC	NDA	Current
78206-180	ZOCOR	SIMVASTATIN	Organon LLC	NDA	Current
78206-180	ZOCOR	SIMVASTATIN	Organon LLC	NDA	Current
78206-181	ZOCOR	SIMVASTATIN	Organon LLC	NDA	Current
78206-181	ZOCOR	SIMVASTATIN	Organon LLC	NDA	Current
78206-181	ZOCOR	SIMVASTATIN	Organon LLC	NDA	Current
78206-182	ZOCOR	SIMVASTATIN	Organon LLC	NDA	Current
78206-182	ZOCOR	SIMVASTATIN	Organon LLC	NDA	Current
78206-182	ZOCOR	SIMVASTATIN	Organon LLC	NDA	Current

Documents

Document	Submission type	Date
75035	SUPPL	2023-08-10
75027	SUPPL	2023-08-10
73769	SUPPL	2023-03-17
73770	SUPPL	2023-03-15
71199	SUPPL	2022-06-01
71186	SUPPL	2022-06-01
70488	SUPPL	2022-03-11
70436	SUPPL	2022-03-08
64724	SUPPL	2020-09-29
64697	SUPPL	2020-09-28
60570	SUPPL	2019-10-15
60420	SUPPL	2019-10-09
57896	SUPPL	2019-03-05
57905	SUPPL	2019-03-04
52778	SUPPL	2018-03-01
52775	SUPPL	2018-03-01
11698	SUPPL	2015-02-03
1590	SUPPL	2015-02-03
11697	SUPPL	2014-03-04
1589	SUPPL	2014-02-28
11696	SUPPL	2013-10-31
1588	SUPPL	2013-10-28
19182	SUPPL	2012-11-05
1587	SUPPL	2012-11-05
33932	SUPPL	2012-11-02
11695	SUPPL	2012-11-02
41008	SUPPL	2012-06-06
11694	SUPPL	2012-03-01
19181	SUPPL	2012-02-29
33931	SUPPL	2011-10-12
1586	SUPPL	2011-10-12
41007	SUPPL	2011-08-15
19178	SUPPL	2011-06-17
33930	SUPPL	2011-06-08
33928	SUPPL	2011-06-08
19180	SUPPL	2011-06-08
19177	SUPPL	2011-06-08
1585	SUPPL	2010-11-08
33929	SUPPL	2010-11-04
11693	SUPPL	2010-04-19
19179	SUPPL	2010-04-13
1584	SUPPL	2010-03-08
11692	SUPPL	2010-03-02
40998	SUPPL	2008-08-04
11691	SUPPL	2008-06-19
19176	SUPPL	2008-06-13
40993	SUPPL	2008-04-04
20327	SUPPL	2008-04-04
20325	SUPPL	2008-04-04
20317	SUPPL	2008-04-04
20316	SUPPL	2008-04-04
41004	SUPPL	2008-02-19
41003	SUPPL	2008-02-19
41002	SUPPL	2008-02-19
41001	SUPPL	2008-02-19
41000	SUPPL	2008-02-19
40999	SUPPL	2008-02-19
40996	SUPPL	2008-02-19
20334	SUPPL	2008-02-19
20333	SUPPL	2008-02-19
20326	SUPPL	2008-02-19
20321	SUPPL	2008-02-19
20320	SUPPL	2008-02-19
20319	SUPPL	2008-02-19
20318	SUPPL	2008-02-19
44036	ORIG	2008-01-25
19175	SUPPL	2007-12-03
11690	SUPPL	2007-12-03
20331	SUPPL	2007-11-19
20330	SUPPL	2007-11-19
44446	ORIG	2007-07-09
41006	SUPPL	2007-07-06
20335	SUPPL	2007-07-06
33927	SUPPL	2007-06-04
1583	SUPPL	2007-06-04
41005	SUPPL	2007-04-09
11689	SUPPL	2005-09-08
1582	SUPPL	2005-09-08
33926	SUPPL	2005-05-20
19174	SUPPL	2005-05-20
11688	SUPPL	2004-04-05
11687	SUPPL	2004-04-05
19173	SUPPL	2004-02-25
19172	SUPPL	2004-02-25
19171	SUPPL	2003-09-29
1581	SUPPL	2003-09-29
11686	SUPPL	2003-09-25
11685	SUPPL	2003-09-25
11683	SUPPL	2003-06-16
19170	SUPPL	2003-05-29
11684	SUPPL	2003-04-17
33925	SUPPL	2002-10-18
19169	SUPPL	2002-10-18
33923	SUPPL	2002-05-06
19167	SUPPL	2002-05-06
33924	SUPPL	2002-03-21
20332	SUPPL	2002-03-21
19168	SUPPL	2002-03-21
33922	SUPPL	2000-04-27
20329	SUPPL	2000-04-27