FDA.reportPublic FDA data

Application 022056

Type
NDA
Sponsor
COVIS PHARMA BV

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PRILOSECOMEPRAZOLE MAGNESIUMFOR SUSPENSION, DELAYED RELEASE;ORALEQ 2.5MG BASE/PACKETYesNo
002PRILOSECOMEPRAZOLE MAGNESIUMFOR SUSPENSION, DELAYED RELEASE;ORALEQ 10MG BASE/PACKETYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0186-0610PRILOSECOmeprazole magnesiumAstraZeneca Pharmaceuticals LPNDACurrent
0186-0625PRILOSECOmeprazole magnesiumAstraZeneca Pharmaceuticals LPNDACurrent
66993-426Omeprazole magnesiumomeprazole magnesiumPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-427Omeprazole magnesiumomeprazole magnesiumPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
70515-610Prilosecomeprazole magnesiumCovis PharmaNDACurrent
70515-610Prilosecomeprazole magnesiumCovis PharmaNDACurrent
70515-610Prilosecomeprazole magnesiumCovis Pharma US, IncNDACurrent
70515-610Prilosecomeprazole magnesiumCovis PharmaNDACurrent
70515-610Prilosecomeprazole magnesiumCovis Pharma US, IncNDACurrent
70515-625Prilosecomeprazole magnesiumCovis PharmaNDACurrent
70515-625Prilosecomeprazole magnesiumCovis PharmaNDACurrent
70515-625Prilosecomeprazole magnesiumCovis Pharma US, IncNDACurrent
70515-625Prilosecomeprazole magnesiumCovis PharmaNDACurrent
70515-625Prilosecomeprazole magnesiumCovis Pharma US, IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74818SUPPL 2023-07-20
74817SUPPL 2023-07-20
74780SUPPL 2023-07-19
70472SUPPL2022-03-10
70471SUPPL2022-03-10
70427SUPPL2022-03-07
70426SUPPL2022-03-07
65400SUPPL2020-11-30
65399SUPPL2020-11-30
65386SUPPL2020-11-30
55460SUPPL2018-09-12
55459SUPPL2018-09-12
55318SUPPL2018-08-24
55297SUPPL2018-08-24
55296SUPPL2018-08-24
54583SUPPL2018-06-14
54523SUPPL2018-06-11
46477SUPPL2016-12-22
46491SUPPL2016-12-21
45715SUPPL2016-10-31
45657SUPPL2016-10-26
38155SUPPL2016-02-11
6784SUPPL2016-02-04
38154SUPPL2014-12-29
6783SUPPL2014-12-24
29165SUPPL2014-04-14
16857SUPPL2014-04-01
29166SUPPL2014-02-27
16858SUPPL2014-02-27
38153SUPPL2013-05-21
6782SUPPL2013-05-16
16855SUPPL2012-10-12
29164SUPPL2012-10-11
6781SUPPL2012-10-02
16856SUPPL2012-10-01
16854SUPPL2012-02-06
29163SUPPL2012-01-24
23695ORIG2011-12-20
38150SUPPL2011-07-06
6778SUPPL2011-07-06
38152SUPPL2011-05-25
6780SUPPL2011-05-25
6779SUPPL2011-01-25
38151SUPPL2011-01-24
16853SUPPL2010-09-10
6777SUPPL2010-09-08
42403ORIG2010-03-16
24237ORIG2010-03-16
29162SUPPL2010-03-08
38149SUPPL2010-03-05
16852SUPPL2008-12-04
6776SUPPL2008-12-04
29161ORIG2008-03-24
16851ORIG2008-03-24
68836ORIG1900-01-01
67205ORIG1900-01-01
67204ORIG1900-01-01
67069ORIG1900-01-01
67068ORIG1900-01-01
51452SUPPL1900-01-01
51450SUPPL1900-01-01