FDA.reportPublic FDA data

Application 022101

Type
NDA
Sponsor
ASTRAZENECA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NEXIUMESOMEPRAZOLE MAGNESIUMFOR SUSPENSION, DELAYED RELEASE;ORALEQ 10MG BASE/PACKETYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0186-4010NEXIUMEsomeprazole magnesiumAstraZeneca Pharmaceuticals LPNDACurrent
0186-4010NEXIUMEsomeprazole magnesiumAstraZeneca Pharmaceuticals LPNDACurrent
0186-4010NEXIUMEsomeprazole magnesiumAstraZeneca Pharmaceuticals LPNDACurrent
0186-4010NEXIUMEsomeprazole magnesiumAstraZeneca Pharmaceuticals LPNDACurrent
0186-4010NEXIUMEsomeprazole magnesiumAstraZeneca Pharmaceuticals LPNDACurrent
0186-4010NEXIUMEsomeprazole magnesiumAstraZeneca Pharmaceuticals LPNDACurrent
0186-4010NEXIUMEsomeprazole magnesiumAstraZeneca Pharmaceuticals LPNDACurrent
0186-4010NEXIUMEsomeprazole magnesiumAstraZeneca Pharmaceuticals LPNDACurrent
0186-4010NEXIUMEsomeprazole magnesiumAstraZeneca Pharmaceuticals LPNDACurrent
0186-4010NEXIUMEsomeprazole magnesiumAstraZeneca Pharmaceuticals LPNDACurrent
0186-4010NEXIUMEsomeprazole magnesiumAstraZeneca Pharmaceuticals LPNDACurrent
0186-4010NEXIUMEsomeprazole magnesiumAstraZeneca PharmaceuticaNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74838SUPPL 2023-07-20
74837SUPPL 2023-07-20
74800SUPPL 2023-07-19
70460SUPPL2022-03-10
70459SUPPL2022-03-10
70413SUPPL2022-03-07
68491SUPPL2021-08-31
68490SUPPL2021-08-31
68479SUPPL2021-08-27
65411SUPPL2020-11-30
65410SUPPL2020-11-30
65381SUPPL2020-11-30
54567SUPPL2018-06-14
54502SUPPL2018-06-11
54499SUPPL2018-06-11
46481SUPPL2016-12-22
46485SUPPL2016-12-21
45694SUPPL2016-10-28
45661SUPPL2016-10-26
38240SUPPL2014-12-29
29243SUPPL2014-12-24
16932SUPPL2014-04-01
6881SUPPL2014-03-28
29242SUPPL2014-02-27
16933SUPPL2014-02-27
38239SUPPL2012-12-10
29241SUPPL2012-11-29
16931SUPPL2012-10-12
6880SUPPL2012-10-11
29240SUPPL2012-10-02
38238SUPPL2012-10-01
38237SUPPL2012-01-24
6879SUPPL2012-01-24
23698ORIG2011-12-20
38236SUPPL2011-07-06
29239SUPPL2011-07-06
38234SUPPL2011-06-29
6877SUPPL2011-06-27
38235SUPPL2010-09-10
6878SUPPL2010-09-09
44677ORIG2010-03-17
42413ORIG2010-03-17
29238SUPPL2010-03-08
38233SUPPL2010-03-05
29237SUPPL2009-11-25
38232SUPPL2009-10-14
29236SUPPL2009-01-21
16930SUPPL2009-01-16
6876ORIG2008-02-29
38231ORIG2008-02-28
53263ORIG1900-01-01
53262ORIG1900-01-01
53261ORIG1900-01-01