FDA.reportPublic FDA data

Application 204736

Type
NDA
Sponsor
AYTU

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACIPHEX SPRINKLERABEPRAZOLE SODIUMCAPSULE, DELAYED RELEASE;ORAL5MGYesNo
002ACIPHEX SPRINKLERABEPRAZOLE SODIUMCAPSULE, DELAYED RELEASE;ORAL10MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
23594-205AcipHexrabeprazole sodiumCerecor, Inc.NDACurrent
23594-205AcipHexrabeprazole sodiumAytu Therapeutics, LLCNDACurrent
23594-205AcipHexrabeprazole sodiumAytu Therapeutics, LLCNDACurrent
23594-205AcipHexrabeprazole sodiumCerecor, Inc.NDACurrent
23594-205AcipHexrabeprazole sodiumAytu Therapeutics, LLCNDACurrent
23594-205AcipHexrabeprazole sodiumZylera Pharmaceuticals, LNDACurrent
23594-210AcipHexrabeprazole sodiumCerecor, Inc.NDACurrent
23594-210AcipHexrabeprazole sodiumAytu Therapeutics, LLCNDACurrent
23594-210AcipHexrabeprazole sodiumAytu Therapeutics, LLCNDACurrent
23594-210AcipHexrabeprazole sodiumCerecor, Inc.NDACurrent
23594-210AcipHexrabeprazole sodiumAytu Therapeutics, LLCNDACurrent
23594-210AcipHexrabeprazole sodiumZylera Pharmaceuticals, LNDACurrent
72834-210rabeprazole sodium delayed-releaserabeprazole sodiumSarras Health, LLCNDA AUTHORIZED GENERICCurrent
72834-210rabeprazole sodium delayed-releaserabeprazole sodiumSarras Health, LLCNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65429SUPPL2020-12-01
65372SUPPL2020-11-30
65371SUPPL2020-11-30
54580SUPPL2018-06-14
54520SUPPL2018-06-11
54519SUPPL2018-06-11
49135SUPPL2017-07-28
49121SUPPL2017-07-28
45644SUPPL2016-10-26
32585SUPPL2016-04-06
19591SUPPL2016-04-05
40419SUPPL2014-12-29
32587SUPPL2014-12-24
32586SUPPL2014-10-21
40418SUPPL2014-10-16
43476ORIG2013-12-06
40417ORIG2013-04-01
10385ORIG2013-03-28
51632ORIG1900-01-01
51631ORIG1900-01-01
51630ORIG1900-01-01