FDA.reportPublic FDA data

Application 210428

Type
NDA
Sponsor
SPIL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KAPSPARGO SPRINKLEMETOPROLOL SUCCINATECAPSULE, EXTENDED RELEASE;ORALEQ 25MG TARTRATEYesNo
002KAPSPARGO SPRINKLEMETOPROLOL SUCCINATECAPSULE, EXTENDED RELEASE;ORALEQ 50MG TARTRATEYesNo
003KAPSPARGO SPRINKLEMETOPROLOL SUCCINATECAPSULE, EXTENDED RELEASE;ORALEQ 100MG TARTRATEYesNo
004KAPSPARGO SPRINKLEMETOPROLOL SUCCINATECAPSULE, EXTENDED RELEASE;ORALEQ 200MG TARTRATEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10631-008KAPSPARGOMetoprolol SuccinateSun Pharmaceutical Industries, Inc.NDACurrent
10631-008KapspargoMetoprolol SuccinateSun Pharmaceutical Industries, Inc.NDACurrent
10631-009KAPSPARGOMetoprolol SuccinateSun Pharmaceutical Industries, Inc.NDACurrent
10631-009KapspargoMetoprolol SuccinateSun Pharmaceutical Industries, Inc.NDACurrent
10631-010KAPSPARGOMetoprolol SuccinateSun Pharmaceutical Industries, Inc.NDACurrent
10631-010KapspargoMetoprolol SuccinateSun Pharmaceutical Industries, Inc.NDACurrent
10631-011KAPSPARGOMetoprolol SuccinateSun Pharmaceutical Industries, Inc.NDACurrent
10631-011KapspargoMetoprolol SuccinateSun Pharmaceutical Industries, Inc.NDACurrent
63304-008Metoprolol SuccinateMetoprolol SuccinateSun Pharmaceutical Industries Inc.NDACurrent
63304-009Metoprolol SuccinateMetoprolol SuccinateSun Pharmaceutical Industries Inc.NDACurrent
63304-010Metoprolol SuccinateMetoprolol SuccinateSun Pharmaceutical Industries Inc.NDACurrent
63304-011Metoprolol SuccinateMetoprolol SuccinateSun Pharmaceutical Industries Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74010SUPPL 2023-04-17
74004SUPPL 2023-04-17
55870ORIG2018-10-11
54245SUPPL2018-05-17
52132ORIG2018-01-30
52082ORIG2018-01-30
63172ORIG1900-01-01
63171ORIG1900-01-01