FDA.report

Application 021229

Type
NDA
Sponsor
ASTRAZENECA PHARMS

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001PRILOSEC OTCOMEPRAZOLE MAGNESIUMTABLET, DELAYED RELEASE;ORALEQ 20MG BASEYesYes

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
37000-455Prilosec OTComeprazole magnesiumThe Procter & Gamble Manufacturing CompanyNDACurrent
37000-455Prilosec OTComeprazole magnesiumThe Procter & Gamble Manufacturing CompanyNDACurrent
37000-455Prilosec OTComeprazole magnesiumThe Procter & Gamble Manufacturing CompanyNDACurrent
37000-455Prilosec OTComeprazole magnesiumThe Procter & Gamble Manufacturing CompanyNDACurrent
37000-459Prilosec OTCOMEPRAZOLE MAGNESIUMThe Procter & Gamble Manufacturing CompanyNDACurrent
37000-459Prilosec OTCOMEPRAZOLE MAGNESIUMThe Procter & Gamble Manufacturing CompanyNDACurrent
37000-459Prilosec OTCOMEPRAZOLE MAGNESIUMThe Procter & Gamble Manufacturing CompanyNDACurrent
37000-459Prilosec OTCOMEPRAZOLE MAGNESIUMThe Procter & Gamble Manufacturing CompanyNDACurrent
70518-2167Prilosec OTComeprazole magnesiumREMEDYREPACK INC.NDACurrent
70518-2167Prilosec OTComeprazole magnesiumREMEDYREPACK INC.NDACurrent
70518-2167Prilosec OTComeprazole magnesiumREMEDYREPACK INC.NDACurrent

Documents

DocumentSubmission typeDate
72343SUPPL2022-10-14
72247SUPPL2022-10-05
61887SUPPL2020-02-14
61747SUPPL2020-01-31
58241SUPPL2019-04-08
58240SUPPL2019-04-08
54617SUPPL2018-06-20
54599SUPPL2018-06-14
53626SUPPL2018-04-05
53619SUPPL2018-04-05
45691SUPPL2016-10-27
45545SUPPL2016-10-14
36421SUPPL2015-07-02
27151SUPPL2015-06-24
14687SUPPL2013-09-19
27150SUPPL2013-09-10
4713SUPPL2012-09-14
14686SUPPL2012-03-27
4712SUPPL2011-08-31
4711SUPPL2011-07-25
27149SUPPL2011-06-29
27148SUPPL2011-03-02
27147SUPPL2010-12-22
27146SUPPL2010-07-08
27145SUPPL2009-11-10
27144SUPPL2008-06-20
4710SUPPL2008-03-04
4709SUPPL2008-01-24
27143SUPPL2007-03-23
14685SUPPL2007-03-23
27142SUPPL2006-10-05
14684SUPPL2006-10-05
42043ORIG2005-04-08
36420SUPPL2004-12-30
4708SUPPL2004-12-30
27141ORIG2003-06-24
23636ORIG2003-06-20
14683ORIG2003-06-20