FDA.reportPublic FDA data

Application 021153

Type
NDA
Sponsor
ASTRAZENECA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NEXIUMESOMEPRAZOLE MAGNESIUMCAPSULE, DELAYED REL PELLETS;ORALEQ 20MG BASEYesNo
002NEXIUMESOMEPRAZOLE MAGNESIUMCAPSULE, DELAYED REL PELLETS;ORALEQ 40MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0186-0382Esomeprazole magnesiumEsomeprazole magnesiumAstraZeneca PharmaceuticaNDA AUTHORIZED Current
0186-0382Esomeprazole magnesiumEsomeprazole magnesiumAstraZeneca Pharmaceuticals LPNDA AUTHORIZED GENERICCurrent
0186-0382Esomeprazole magnesiumEsomeprazole magnesiumAstraZeneca Pharmaceuticals LPNDA AUTHORIZED GENERICCurrent
0186-0382Esomeprazole magnesiumEsomeprazole magnesiumAstraZeneca Pharmaceuticals LPNDA AUTHORIZED GENERICCurrent
0186-0382Esomeprazole magnesiumEsomeprazole magnesiumAstraZeneca Pharmaceuticals LPNDA AUTHORIZED GENERICCurrent
0186-0384Esomeprazole magnesiumEsomeprazole magnesiumAstraZeneca Pharmaceuticals LPNDA AUTHORIZED GENERICCurrent
0186-0384Esomeprazole magnesiumEsomeprazole magnesiumAstraZeneca PharmaceuticaNDA AUTHORIZED Current
0186-0384Esomeprazole magnesiumEsomeprazole magnesiumAstraZeneca Pharmaceuticals LPNDA AUTHORIZED GENERICCurrent
0186-0384Esomeprazole magnesiumEsomeprazole magnesiumAstraZeneca Pharmaceuticals LPNDA AUTHORIZED GENERICCurrent
0186-0384Esomeprazole magnesiumEsomeprazole magnesiumAstraZeneca Pharmaceuticals LPNDA AUTHORIZED GENERICCurrent
0186-5020NEXIUMEsomeprazole magnesiumAstraZeneca Pharmaceuticals LPNDACurrent
0186-5020NEXIUMEsomeprazole magnesiumAstraZeneca PharmaceuticaNDACurrent
0186-5020NEXIUMEsomeprazole magnesiumAstraZeneca Pharmaceuticals LPNDACurrent
0186-5020NEXIUMEsomeprazole magnesiumAstraZeneca Pharmaceuticals LPNDACurrent
0186-5020NEXIUMEsomeprazole magnesiumAstraZeneca Pharmaceuticals LPNDACurrent
0186-5020NEXIUMEsomeprazole magnesiumAstraZeneca Pharmaceuticals LPNDACurrent
0186-5020NEXIUMEsomeprazole magnesiumAstraZeneca Pharmaceuticals LPNDACurrent
0186-5020NEXIUMEsomeprazole magnesiumAstraZeneca Pharmaceuticals LPNDACurrent
0186-5020NEXIUMEsomeprazole magnesiumAstraZeneca Pharmaceuticals LPNDACurrent
0186-5020NEXIUMEsomeprazole magnesiumAstraZeneca Pharmaceuticals LPNDACurrent
0186-5020NEXIUMEsomeprazole magnesiumAstraZeneca Pharmaceuticals LPNDACurrent
0186-5020NEXIUMEsomeprazole magnesiumAstraZeneca Pharmaceuticals LPNDACurrent
0186-5040NEXIUMEsomeprazole magnesiumAstraZeneca Pharmaceuticals LPNDACurrent
0186-5040NEXIUMEsomeprazole magnesiumAstraZeneca PharmaceuticaNDACurrent
0186-5040NEXIUMEsomeprazole magnesiumAstraZeneca Pharmaceuticals LPNDACurrent
0186-5040NEXIUMEsomeprazole magnesiumAstraZeneca Pharmaceuticals LPNDACurrent
0186-5040NEXIUMEsomeprazole magnesiumAstraZeneca Pharmaceuticals LPNDACurrent
0186-5040NEXIUMEsomeprazole magnesiumAstraZeneca Pharmaceuticals LPNDACurrent
0186-5040NEXIUMEsomeprazole magnesiumAstraZeneca Pharmaceuticals LPNDACurrent
0186-5040NEXIUMEsomeprazole magnesiumAstraZeneca Pharmaceuticals LPNDACurrent
0186-5040NEXIUMEsomeprazole magnesiumAstraZeneca Pharmaceuticals LPNDACurrent
0186-5040NEXIUMEsomeprazole magnesiumAstraZeneca Pharmaceuticals LPNDACurrent
0186-5040NEXIUMEsomeprazole magnesiumAstraZeneca Pharmaceuticals LPNDACurrent
0186-5040NEXIUMEsomeprazole magnesiumAstraZeneca Pharmaceuticals LPNDACurrent
21695-091NEXIUMEsomeprazole magnesiumRebel Distributors CorpNDACurrent
21695-092NEXIUMEsomeprazole magnesiumRebel Distributors CorpNDACurrent
49999-307NEXIUMEsomeprazole magnesiumLake Erie Medical DBA Quality Care Products LLCNDACurrent
50090-0742NEXIUMEsomeprazole magnesiumA-S Medication SolutionsNDACurrent
50090-0742NEXIUMEsomeprazole magnesiumA-S Medication SolutionsNDACurrent
50090-4639Esomeprazole magnesiumEsomeprazole magnesiumA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-4639Esomeprazole magnesiumEsomeprazole magnesiumA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50436-3121NEXIUMEsomeprazole magnesiumUnit Dose ServicesNDACurrent
55154-9616NEXIUMEsomeprazole magnesiumCardinal HealthNDACurrent
55700-046NEXIUMEsomeprazole magnesiumLake Erie Medical DBA Quality Care Products LLCNDACurrent
61919-509NEXIUMesomeprazole magnesiumDIRECT RXNDACurrent
63629-3311NEXIUMEsomeprazole magnesiumBryant Ranch PrepackNDACurrent
63629-3311NEXIUMEsomeprazole magnesiumBryant Ranch PrepackNDACurrent
70518-2038NEXIUMEsomeprazole magnesiumREMEDYREPACK INC.NDACurrent
70518-2038NEXIUMEsomeprazole magnesiumREMEDYREPACK INC.NDACurrent
70518-2038NEXIUMEsomeprazole magnesiumREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74834SUPPL 2023-07-20
74833SUPPL 2023-07-20
74798SUPPL 2023-07-19
70461SUPPL2022-03-10
70456SUPPL2022-03-10
70411SUPPL2022-03-07
68487SUPPL2021-08-31
68486SUPPL2021-08-31
68477SUPPL2021-08-27
65407SUPPL2020-11-30
65406SUPPL2020-11-30
65379SUPPL2020-11-30
54568SUPPL2018-06-14
54503SUPPL2018-06-11
54498SUPPL2018-06-11
46480SUPPL2016-12-22
46488SUPPL2016-12-21
45693SUPPL2016-10-28
45660SUPPL2016-10-26
36230SUPPL2014-12-29
26927SUPPL2014-12-24
41992SUPPL2014-08-05
21481SUPPL2014-08-05
21480SUPPL2014-08-05
36229SUPPL2014-04-01
4493SUPPL2014-03-28
14527SUPPL2014-03-05
26926SUPPL2014-02-27
14526SUPPL2012-12-10
26925SUPPL2012-11-29
41990SUPPL2012-10-12
14524SUPPL2012-10-12
4491SUPPL2012-10-11
4492SUPPL2012-10-02
14525SUPPL2012-10-01
26924SUPPL2012-01-24
14523SUPPL2012-01-24
44101ORIG2011-12-20
26923SUPPL2011-07-06
14522SUPPL2011-07-06
14521SUPPL2011-06-29
4489SUPPL2011-06-27
36228SUPPL2010-09-10
4490SUPPL2010-09-09
4488SUPPL2010-03-08
14520SUPPL2010-03-05
4487SUPPL2009-11-25
36227SUPPL2009-10-14
26922SUPPL2009-01-21
14519SUPPL2009-01-16
51725ORIG2008-10-02
41991SUPPL2008-02-19
26921SUPPL2008-01-18
36226SUPPL2007-05-01
14518SUPPL2007-05-01
4486SUPPL2007-05-01
51724ORIG2007-03-29
4484SUPPL2006-10-18
36225SUPPL2006-10-13
26920SUPPL2006-10-02
14517SUPPL2006-09-27
4485SUPPL2006-09-20
14516SUPPL2006-09-18
26919SUPPL2006-05-02
14515SUPPL2006-05-02
26918SUPPL2006-03-01
14514SUPPL2006-02-22
51723ORIG2005-12-20
51722ORIG2005-12-20
14513SUPPL2005-06-08
4483SUPPL2005-06-08
36224SUPPL2004-12-03
26917SUPPL2004-12-02
14512SUPPL2004-05-04
26916SUPPL2004-04-29
41989SUPPL2004-04-14
36223SUPPL2004-01-15
4482SUPPL2004-01-14
26915SUPPL2003-03-10
4481SUPPL2002-09-20
51721ORIG2001-12-31
41988ORIG2001-02-20
36222ORIG2001-02-20
26914ORIG2001-02-20
67176ORIG1900-01-01