FDA.reportPublic FDA data

Application 021849

Type
NDA
Sponsor
SALIX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZEGERIDOMEPRAZOLE; SODIUM BICARBONATECAPSULE;ORAL20MG;1.1GMYesNo
002ZEGERIDOMEPRAZOLE; SODIUM BICARBONATECAPSULE;ORAL40MG;1.1GMYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
66993-412omeprazole/sodium bicarbonateomeprazole, sodium bicarbonatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-413omeprazole/sodium bicarbonateomeprazole, sodium bicarbonatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
68012-102ZEGERIDomeprazole and sodium bicarbonateSantarus, Inc..NDACurrent
68012-102ZEGERIDomeprazole and sodium bicarbonateSantarus, Inc..NDACurrent
68012-102ZEGERIDomeprazole and sodium bicarbonateSantarus, Inc..NDACurrent
68012-102ZEGERIDomeprazole and sodium bicarbonateSantarus, Inc..NDACurrent
68012-102ZEGERIDomeprazole and sodium bicarbonateSantarus, Inc..NDACurrent
68012-102ZEGERIDomeprazole and sodium bicarbonateSantarus, Inc..NDACurrent
68012-102ZEGERIDomeprazole and sodium bicarbonateSantarus, Inc..NDACurrent
68012-102ZEGERIDomeprazole and sodium bicarbonateSantarus, Inc..NDACurrent
68012-102ZEGERIDomeprazole and sodium bicarbonateSantarus, Inc..NDACurrent
68012-102ZEGERIDomeprazole and sodium bicarbonateSantarus, Inc..NDACurrent
68012-102ZEGERIDomeprazole and sodium bicarbonateSantarus, Inc..NDACurrent
68012-104ZEGERIDomeprazole and sodium bicarbonateSantarus, Inc..NDACurrent
68012-104ZEGERIDomeprazole and sodium bicarbonateSantarus, Inc..NDACurrent
68012-104ZEGERIDomeprazole and sodium bicarbonateSantarus, Inc..NDACurrent
68012-104ZEGERIDomeprazole and sodium bicarbonateSantarus, Inc..NDACurrent
68012-104ZEGERIDomeprazole and sodium bicarbonateSantarus, Inc..NDACurrent
68012-104ZEGERIDomeprazole and sodium bicarbonateSantarus, Inc..NDACurrent
68012-104ZEGERIDomeprazole and sodium bicarbonateSantarus, Inc..NDACurrent
68012-104ZEGERIDomeprazole and sodium bicarbonateSantarus, Inc..NDACurrent
68012-104ZEGERIDomeprazole and sodium bicarbonateSantarus, Inc..NDACurrent
68012-104ZEGERIDomeprazole and sodium bicarbonateSantarus, Inc..NDACurrent
68012-104ZEGERIDomeprazole and sodium bicarbonateSantarus, Inc..NDACurrent
68682-102Omeprazole and Sodium Bicarbonateomeprazole, sodium bicarbonateOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-102Omeprazole and Sodium Bicarbonateomeprazole, sodium bicarbonateOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-102Omeprazole and Sodium Bicarbonateomeprazole, sodium bicarbonateOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-102Omeprazole and Sodium Bicarbonateomeprazole, sodium bicarbonateOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-102Omeprazole and Sodium Bicarbonateomeprazole, sodium bicarbonateOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-102Omeprazole and Sodium Bicarbonateomeprazole, sodium bicarbonateOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-104Omeprazole and Sodium Bicarbonateomeprazole, sodium bicarbonateOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-104Omeprazole and Sodium Bicarbonateomeprazole, sodium bicarbonateOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-104Omeprazole and Sodium Bicarbonateomeprazole, sodium bicarbonateOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-104Omeprazole and Sodium Bicarbonateomeprazole, sodium bicarbonateOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-104Omeprazole and Sodium Bicarbonateomeprazole, sodium bicarbonateOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-104Omeprazole and Sodium Bicarbonateomeprazole, sodium bicarbonateOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74829SUPPL 2023-07-20
74828SUPPL 2023-07-20
74792SUPPL 2023-07-19
70469SUPPL2022-03-10
70468SUPPL2022-03-10
70425SUPPL2022-03-07
68016SUPPL2021-07-06
68011SUPPL2021-07-06
65405SUPPL2020-11-30
65404SUPPL2020-11-30
65383SUPPL2020-11-30
60108SUPPL2019-09-25
60105SUPPL2019-09-25
60104SUPPL2019-09-25
54576SUPPL2018-06-14
54532SUPPL2018-06-12
45720SUPPL2016-10-31
45665SUPPL2016-10-26
16455SUPPL2014-12-29
6302SUPPL2014-12-24
28709SUPPL2014-03-04
37759SUPPL2014-02-27
16453SUPPL2012-11-15
6301SUPPL2012-11-14
28708SUPPL2012-04-23
16454SUPPL2012-04-20
23679ORIG2011-12-20
37758SUPPL2011-12-15
28707SUPPL2011-12-13
21841SUPPL2011-10-10
28706SUPPL2011-05-25
16452SUPPL2011-05-25
16451SUPPL2010-09-10
6300SUPPL2010-09-08
6299SUPPL2010-01-29
21840ORIG2008-05-07
28705SUPPL2008-01-09
37757SUPPL2008-01-08
37756ORIG2006-03-03
6298ORIG2006-03-03