FDA.reportPublic FDA data

Application 020237

Type
NDA
Sponsor
CONCORDIA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SALAGENPILOCARPINE HYDROCHLORIDETABLET;ORAL5MGYesNo
002SALAGENPILOCARPINE HYDROCHLORIDETABLET;ORAL7.5MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0228-2801Pilocarpine hydrochloridePilocarpine hydrochlorideActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0228-2801Pilocarpine hydrochloridePilocarpine hydrochlorideActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0228-2801Pilocarpine hydrochloridePilocarpine hydrochlorideActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0228-2837Pilocarpine hydrochloridePilocarpine hydrochlorideActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0228-2837Pilocarpine hydrochloridePilocarpine hydrochlorideActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0228-2837Pilocarpine hydrochloridePilocarpine hydrochlorideActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
59212-705SalagenPilocarpine HydrochlorideConcordia Pharmaceuticals Inc.NDACurrent
59212-705SalagenPilocarpine HydrochlorideConcordia Pharmaceuticals Inc.NDACurrent
59212-705SalagenPilocarpine HydrochlorideConcordia Pharmaceuticals Inc.NDACurrent
59212-775SalagenPilocarpine HydrochlorideConcordia Pharmaceuticals Inc.NDACurrent
59212-775SalagenPilocarpine HydrochlorideConcordia Pharmaceuticals Inc.NDACurrent
59212-775SalagenPilocarpine HydrochlorideConcordia Pharmaceuticals Inc.NDACurrent
62856-705Salagenpilocarpine hyrochlorideEisai Inc.NDACurrent
62856-705Salagenpilocarpine hyrochlorideEisai Inc.NDACurrent
62856-705Salagenpilocarpine hyrochlorideEisai Inc.NDACurrent
62856-775Salagenpilocarpine hyrochlorideEisai Inc.NDACurrent
62856-775Salagenpilocarpine hyrochlorideEisai Inc.NDACurrent
62856-775Salagenpilocarpine hyrochlorideEisai Inc.NDACurrent
68084-928Pilocarpine hydrochloridePilocarpine hydrochlorideAmerican Health PackagingNDA AUTHORIZED GENERICCurrent
68084-928Pilocarpine hydrochloridePilocarpine hydrochlorideAmerican Health PackagingNDA AUTHORIZED GENERICCurrent
68084-928Pilocarpine hydrochloridePilocarpine hydrochlorideAmerican Health PackagingNDA AUTHORIZED GENERICCurrent
68084-928Pilocarpine hydrochloridePilocarpine hydrochlorideAmerican Health PackagingNDA AUTHORIZED GENERICCurrent
68151-3015Pilocarpine hydrochloridePilocarpine hydrochlorideCarilion Materials ManagementNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
20547SUPPL2007-07-06
24630SUPPL2004-06-07
2221SUPPL2004-06-07
24632SUPPL2003-05-29
12351SUPPL2003-04-28
34410SUPPL2002-06-10
24631SUPPL2002-06-10
12350SUPPL2002-06-10
2223SUPPL2002-06-10
20546SUPPL1998-02-11
2222SUPPL1998-02-11