FDA.reportPublic FDA data

Application 021169

Type
NDA
Sponsor
JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RAZADYNEGALANTAMINE HYDROBROMIDETABLET;ORALEQ 4MG BASEYesYes
002RAZADYNEGALANTAMINE HYDROBROMIDETABLET;ORALEQ 8MG BASEYesNo
003RAZADYNEGALANTAMINE HYDROBROMIDETABLET;ORALEQ 12MG BASEYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10147-0881galantamine hydrobromidegalantamine hydrobromidePatriot Pharmaceuticals, LLCNDACurrent
10147-0881galantamine hydrobromidegalantamine hydrobromidePatriot Pharmaceuticals, LLCNDACurrent
10147-0881galantamine hydrobromidegalantamine hydrobromidePatriot Pharmaceuticals, LLCNDACurrent
10147-0881galantamine hydrobromidegalantamine hydrobromidePatriot Pharmaceuticals, LLCNDACurrent
10147-0882galantamine hydrobromidegalantamine hydrobromidePatriot Pharmaceuticals, LLCNDACurrent
10147-0882galantamine hydrobromidegalantamine hydrobromidePatriot Pharmaceuticals, LLCNDACurrent
10147-0882galantamine hydrobromidegalantamine hydrobromidePatriot Pharmaceuticals, LLCNDACurrent
10147-0882galantamine hydrobromidegalantamine hydrobromidePatriot Pharmaceuticals, LLCNDACurrent
10147-0883galantamine hydrobromidegalantamine hydrobromidePatriot Pharmaceuticals, LLCNDACurrent
10147-0883galantamine hydrobromidegalantamine hydrobromidePatriot Pharmaceuticals, LLCNDACurrent
10147-0883galantamine hydrobromidegalantamine hydrobromidePatriot Pharmaceuticals, LLCNDACurrent
10147-0883galantamine hydrobromidegalantamine hydrobromidePatriot Pharmaceuticals, LLCNDACurrent
21695-184RAZADYNEgalantamine hydrobromideRebel Distributors CorpNDACurrent
21695-591RAZADYNEgalantamine hydrobromideRebel Distributors CorpNDACurrent
50458-396RAZADYNEgalantamine hydrobromideJanssen Pharmaceuticals, Inc.NDACurrent
50458-396RAZADYNEgalantamine hydrobromideJanssen Pharmaceuticals, Inc.NDACurrent
50458-396RAZADYNEgalantamine hydrobromideJanssen Pharmaceuticals, Inc.NDACurrent
50458-396RAZADYNEgalantamine hydrobromideJanssen Pharmaceuticals, Inc.NDACurrent
50458-396RAZADYNEgalantamine hydrobromideJanssen Pharmaceuticals, Inc.NDACurrent
50458-396RAZADYNEgalantamine hydrobromideJanssen Pharmaceuticals, Inc.NDACurrent
50458-396RAZADYNEgalantamine hydrobromideJanssen Pharmaceuticals, Inc.NDACurrent
50458-397RAZADYNEgalantamine hydrobromideJanssen Pharmaceuticals, Inc.NDACurrent
50458-397RAZADYNEgalantamine hydrobromideJanssen Pharmaceuticals, Inc.NDACurrent
50458-397RAZADYNEgalantamine hydrobromideJanssen Pharmaceuticals, Inc.NDACurrent
50458-397RAZADYNEgalantamine hydrobromideJanssen Pharmaceuticals, Inc.NDACurrent
50458-397RAZADYNEgalantamine hydrobromideJanssen Pharmaceuticals, Inc.NDACurrent
50458-397RAZADYNEgalantamine hydrobromideJanssen Pharmaceuticals, Inc.NDACurrent
50458-398RAZADYNEgalantamine hydrobromideJanssen Pharmaceuticals, Inc.NDACurrent
50458-398RAZADYNEgalantamine hydrobromideJanssen Pharmaceuticals, Inc.NDACurrent
50458-398RAZADYNEgalantamine hydrobromideJanssen Pharmaceuticals, Inc.NDACurrent
50458-398RAZADYNEgalantamine hydrobromideJanssen Pharmaceuticals, Inc.NDACurrent
50458-398RAZADYNEgalantamine hydrobromideJanssen Pharmaceuticals, Inc.NDACurrent
50458-398RAZADYNEgalantamine hydrobromideJanssen Pharmaceuticals, Inc.NDACurrent
51990-111Galantamine Hydrobromidegalantamine hydrobromideYabao Pharmaceutical Co., Ltd. BeijingNDACurrent
51990-112Galantamine Hydrobromidegalantamine hydrobromideYabao Pharmaceutical Co., Ltd. BeijingNDACurrent
51990-113Galantamine Hydrobromidegalantamine hydrobromideYabao Pharmaceutical Co., Ltd. BeijingNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68287SUPPL2021-08-04
68278SUPPL2021-08-04
64848SUPPL2020-10-06
62218SUPPL2020-03-23
61985SUPPL2020-02-27
61950SUPPL2020-02-25
47242SUPPL2017-02-16
47237SUPPL2017-02-16
36271SUPPL2015-12-17
4541SUPPL2015-12-17
26974SUPPL2015-02-12
36270SUPPL2015-02-10
14560SUPPL2013-07-11
4540SUPPL2013-07-02
14561SUPPL2012-05-01
36269SUPPL2012-03-06
36268SUPPL2012-03-06
26973SUPPL2012-03-05
26972SUPPL2012-03-05
4539SUPPL2012-03-05
26971SUPPL2006-05-01
26970SUPPL2006-05-01
4538SUPPL2006-05-01
4537SUPPL2006-05-01
23632ORIG2005-07-29
26969SUPPL2005-05-03
4536SUPPL2003-09-09
26968SUPPL2002-05-02
42000ORIG2001-12-18
14559ORIG2001-02-28
4535ORIG2001-02-28