FDA.reportPublic FDA data

Application 021615

Type
NDA
Sponsor
JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RAZADYNE ERGALANTAMINE HYDROBROMIDECAPSULE, EXTENDED RELEASE;ORALEQ 8MG BASEYesYes
002RAZADYNE ERGALANTAMINE HYDROBROMIDECAPSULE, EXTENDED RELEASE;ORALEQ 16MG BASEYesNo
003RAZADYNE ERGALANTAMINE HYDROBROMIDECAPSULE, EXTENDED RELEASE;ORALEQ 24MG BASEYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10147-0891galantamine hydrobromidegalantamine hydrobromidePatriot Pharmaceuticals, LLCNDACurrent
10147-0891galantamine hydrobromidegalantamine hydrobromidePatriot Pharmaceuticals, LLCNDACurrent
10147-0891galantamine hydrobromidegalantamine hydrobromidePatriot Pharmaceuticals, LLCNDACurrent
10147-0891galantamine hydrobromidegalantamine hydrobromidePatriot Pharmaceuticals, LLCNDACurrent
10147-0891galantamine hydrobromidegalantamine hydrobromidePatriot Pharmaceuticals, LLCNDACurrent
10147-0891galantamine hydrobromidegalantamine hydrobromidePatriot Pharmaceuticals, LLCNDACurrent
10147-0891galantamine hydrobromidegalantamine hydrobromidePatriot Pharmaceuticals, LLCNDACurrent
10147-0891galantamine hydrobromidegalantamine hydrobromidePatriot Pharmaceuticals, LLCNDACurrent
10147-0892galantamine hydrobromidegalantamine hydrobromidePatriot Pharmaceuticals, LLCNDACurrent
10147-0892galantamine hydrobromidegalantamine hydrobromidePatriot Pharmaceuticals, LLCNDACurrent
10147-0892galantamine hydrobromidegalantamine hydrobromidePatriot Pharmaceuticals, LLCNDACurrent
10147-0892galantamine hydrobromidegalantamine hydrobromidePatriot Pharmaceuticals, LLCNDACurrent
10147-0892galantamine hydrobromidegalantamine hydrobromidePatriot Pharmaceuticals, LLCNDACurrent
10147-0892galantamine hydrobromidegalantamine hydrobromidePatriot Pharmaceuticals, LLCNDACurrent
10147-0892galantamine hydrobromidegalantamine hydrobromidePatriot Pharmaceuticals, LLCNDACurrent
10147-0892galantamine hydrobromidegalantamine hydrobromidePatriot Pharmaceuticals, LLCNDACurrent
10147-0893galantamine hydrobromidegalantamine hydrobromidePatriot Pharmaceuticals, LLCNDACurrent
10147-0893galantamine hydrobromidegalantamine hydrobromidePatriot Pharmaceuticals, LLCNDACurrent
10147-0893galantamine hydrobromidegalantamine hydrobromidePatriot Pharmaceuticals, LLCNDACurrent
10147-0893galantamine hydrobromidegalantamine hydrobromidePatriot Pharmaceuticals, LLCNDACurrent
10147-0893galantamine hydrobromidegalantamine hydrobromidePatriot Pharmaceuticals, LLCNDACurrent
10147-0893galantamine hydrobromidegalantamine hydrobromidePatriot Pharmaceuticals, LLCNDACurrent
10147-0893galantamine hydrobromidegalantamine hydrobromidePatriot Pharmaceuticals, LLCNDACurrent
10147-0893galantamine hydrobromidegalantamine hydrobromidePatriot Pharmaceuticals, LLCNDACurrent
50458-387RAZADYNEgalantamine hydrobromideJanssen Pharmaceuticals, Inc.NDACurrent
50458-387RAZADYNEgalantamine hydrobromideJanssen Pharmaceuticals, Inc.NDACurrent
50458-387RAZADYNEgalantamine hydrobromideJanssen Pharmaceuticals, Inc.NDACurrent
50458-387RAZADYNEgalantamine hydrobromideJanssen Pharmaceuticals, Inc.NDACurrent
50458-387RAZADYNEgalantamine hydrobromideJanssen Pharmaceuticals, Inc.NDACurrent
50458-387RAZADYNEgalantamine hydrobromideJanssen Pharmaceuticals, Inc.NDACurrent
50458-387RAZADYNEgalantamine hydrobromideJanssen Pharmaceuticals, Inc.NDACurrent
50458-387RAZADYNEgalantamine hydrobromideJanssen Pharmaceuticals, Inc.NDACurrent
50458-388RAZADYNEgalantamine hydrobromideJanssen Pharmaceuticals, Inc.NDACurrent
50458-388RAZADYNEgalantamine hydrobromideJanssen Pharmaceuticals, Inc.NDACurrent
50458-388RAZADYNEgalantamine hydrobromideJanssen Pharmaceuticals, Inc.NDACurrent
50458-388RAZADYNEgalantamine hydrobromideJanssen Pharmaceuticals, Inc.NDACurrent
50458-388RAZADYNEgalantamine hydrobromideJanssen Pharmaceuticals, Inc.NDACurrent
50458-388RAZADYNEgalantamine hydrobromideJanssen Pharmaceuticals, Inc.NDACurrent
50458-388RAZADYNEgalantamine hydrobromideJanssen Pharmaceuticals, Inc.NDACurrent
50458-388RAZADYNEgalantamine hydrobromideJanssen Pharmaceuticals, Inc.NDACurrent
50458-389RAZADYNEgalantamine hydrobromideJanssen Pharmaceuticals, Inc.NDACurrent
50458-389RAZADYNEgalantamine hydrobromideJanssen Pharmaceuticals, Inc.NDACurrent
50458-389RAZADYNEgalantamine hydrobromideJanssen Pharmaceuticals, Inc.NDACurrent
50458-389RAZADYNEgalantamine hydrobromideJanssen Pharmaceuticals, Inc.NDACurrent
50458-389RAZADYNEgalantamine hydrobromideJanssen Pharmaceuticals, Inc.NDACurrent
50458-389RAZADYNEgalantamine hydrobromideJanssen Pharmaceuticals, Inc.NDACurrent
50458-389RAZADYNEgalantamine hydrobromideJanssen Pharmaceuticals, Inc.NDACurrent
50458-389RAZADYNEgalantamine hydrobromideJanssen Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72162SUPPL2022-09-27
72159SUPPL2022-09-27
68288SUPPL2021-08-04
68285SUPPL2021-08-04
62219SUPPL2020-03-23
61986SUPPL2020-02-27
61951SUPPL2020-02-25
47240SUPPL2017-02-16
47239SUPPL2017-02-16
37342SUPPL2015-12-17
5862SUPPL2015-12-17
28252SUPPL2015-02-12
37341SUPPL2015-02-10
15879SUPPL2013-07-11
28250SUPPL2013-07-02
37340SUPPL2012-05-01
37339SUPPL2012-03-06
15878SUPPL2012-03-06
28251SUPPL2012-03-05
28249SUPPL2012-03-05
5861SUPPL2012-03-05
28248SUPPL2006-05-01
5860SUPPL2006-05-01
5859SUPPL2006-05-01
5857SUPPL2006-05-01
42234ORIG2005-12-05
44138ORIG2005-07-29
5858SUPPL2005-05-03
28247ORIG2004-12-29
15877ORIG2004-12-29