Application 021636

Type: NDA
Sponsor: SALIX

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZEGERID	OMEPRAZOLE; SODIUM BICARBONATE	FOR SUSPENSION;ORAL	20MG/PACKET;1.68GM/PACKET	Yes	No
002	ZEGERID	OMEPRAZOLE; SODIUM BICARBONATE	FOR SUSPENSION;ORAL	40MG/PACKET;1.68GM/PACKET	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68012-052	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68012-052	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68012-052	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68012-052	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68012-052	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68012-052	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68012-052	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68012-052	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68012-052	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68012-052	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68012-052	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68012-054	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68012-054	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68012-054	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68012-054	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68012-054	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68012-054	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68012-054	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68012-054	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68012-054	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68012-054	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68012-054	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68682-990	Omeprazole and Sodium Bicarbonate	omeprazole, sodium bicarbonate	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-990	Omeprazole and Sodium Bicarbonate	omeprazole, sodium bicarbonate	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-990	Omeprazole and Sodium Bicarbonate	omeprazole, sodium bicarbonate	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-990	Omeprazole and Sodium Bicarbonate	omeprazole, sodium bicarbonate	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-990	Omeprazole and Sodium Bicarbonate	omeprazole, sodium bicarbonate	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-990	Omeprazole and Sodium Bicarbonate	omeprazole, sodium bicarbonate	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-991	Omeprazole and Sodium Bicarbonate	omeprazole, sodium bicarbonate	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-991	Omeprazole and Sodium Bicarbonate	omeprazole, sodium bicarbonate	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-991	Omeprazole and Sodium Bicarbonate	omeprazole, sodium bicarbonate	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-991	Omeprazole and Sodium Bicarbonate	omeprazole, sodium bicarbonate	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-991	Omeprazole and Sodium Bicarbonate	omeprazole, sodium bicarbonate	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-991	Omeprazole and Sodium Bicarbonate	omeprazole, sodium bicarbonate	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74831	SUPPL	2023-07-20
74830	SUPPL	2023-07-20
74791	SUPPL	2023-07-19
70498	SUPPL	2022-03-11
70497	SUPPL	2022-03-11
70424	SUPPL	2022-03-07
65403	SUPPL	2020-11-30
65402	SUPPL	2020-11-30
65382	SUPPL	2020-11-30
60107	SUPPL	2019-09-25
60103	SUPPL	2019-09-25
60102	SUPPL	2019-09-25
54577	SUPPL	2018-06-14
54529	SUPPL	2018-06-12
45721	SUPPL	2016-10-31
45666	SUPPL	2016-10-26
15909	SUPPL	2014-12-29
5898	SUPPL	2014-12-24
28289	SUPPL	2014-03-04
37375	SUPPL	2014-02-27
37374	SUPPL	2012-11-15
28288	SUPPL	2012-11-14
5897	SUPPL	2012-04-23
15908	SUPPL	2012-04-20
44139	ORIG	2011-12-20
37373	SUPPL	2011-12-13
28287	SUPPL	2011-12-13
37372	SUPPL	2011-05-25
5896	SUPPL	2011-05-25
15907	SUPPL	2010-09-10
28286	SUPPL	2010-09-08
15906	SUPPL	2010-08-05
5895	SUPPL	2010-01-29
42245	ORIG	2005-12-06
28285	ORIG	2004-06-16
15905	ORIG	2004-06-16

Application 021636

Related Records#

Application Products#

NDC Listings For This Application#

Documents#