FDA.reportPublic FDA data

Application 212516

Type
NDA
Sponsor
SUN PHARMA GLOBAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DRIZALMA SPRINKLEDULOXETINE HYDROCHLORIDECAPSULE, DELAYED RELEASE;ORALEQ 20MG BASEYesNo
002DRIZALMA SPRINKLEDULOXETINE HYDROCHLORIDECAPSULE, DELAYED RELEASE;ORALEQ 30MG BASEYesNo
003DRIZALMA SPRINKLEDULOXETINE HYDROCHLORIDECAPSULE, DELAYED RELEASE;ORALEQ 40MG BASEYesNo
004DRIZALMA SPRINKLEDULOXETINE HYDROCHLORIDECAPSULE, DELAYED RELEASE;ORALEQ 60MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
47335-616DRIZALMA SPRINKLEDuloxetineSUN PHARMACEUTICAL INDUSTRIES, INC.NDACurrent
47335-616DRIZALMA SPRINKLEDuloxetineSUN PHARMACEUTICAL INDUSTRIES, INC.NDACurrent
47335-616DRIZALMA SPRINKLEDuloxetineSUN PHARMACEUTICAL INDUSTRIES, INC.NDACurrent
47335-616DuloxetineDuloxetineSUN PHARMACEUTICAL INDUSTRIES, INC.NDACurrent
47335-616DRIZALMA SPRINKLEDuloxetineSUN PHARMACEUTICAL INDUSTRIES, INC.NDACurrent
47335-617DRIZALMA SPRINKLEDuloxetineSUN PHARMACEUTICAL INDUSTRIES, INC.NDACurrent
47335-617DRIZALMA SPRINKLEDuloxetineSUN PHARMACEUTICAL INDUSTRIES, INC.NDACurrent
47335-617DRIZALMA SPRINKLEDuloxetineSUN PHARMACEUTICAL INDUSTRIES, INC.NDACurrent
47335-617DRIZALMA SPRINKLEDuloxetineSUN PHARMACEUTICAL INDUSTRIES, INC.NDACurrent
47335-617DuloxetineDuloxetineSUN PHARMACEUTICAL INDUSTRIES, INC.NDACurrent
47335-618DRIZALMA SPRINKLEDuloxetineSUN PHARMACEUTICAL INDUSTRIES, INC.NDACurrent
47335-618DuloxetineDuloxetineSUN PHARMACEUTICAL INDUSTRIES, INC.NDACurrent
47335-618DRIZALMA SPRINKLEDuloxetineSUN PHARMACEUTICAL INDUSTRIES, INC.NDACurrent
47335-618DRIZALMA SPRINKLEDuloxetineSUN PHARMACEUTICAL INDUSTRIES, INC.NDACurrent
47335-618DRIZALMA SPRINKLEDuloxetineSUN PHARMACEUTICAL INDUSTRIES, INC.NDACurrent
47335-619DRIZALMA SPRINKLEDuloxetineSUN PHARMACEUTICAL INDUSTRIES, INC.NDACurrent
47335-619DRIZALMA SPRINKLEDuloxetineSUN PHARMACEUTICAL INDUSTRIES, INC.NDACurrent
47335-619DRIZALMA SPRINKLEDuloxetineSUN PHARMACEUTICAL INDUSTRIES, INC.NDACurrent
47335-619DRIZALMA SPRINKLEDuloxetineSUN PHARMACEUTICAL INDUSTRIES, INC.NDACurrent
47335-619DuloxetineDuloxetineSUN PHARMACEUTICAL INDUSTRIES, INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75262SUPPL 2023-08-22
75156SUPPL 2023-08-21
75155SUPPL 2023-08-21
68200SUPPL2021-07-27
68181SUPPL2021-07-26
68180SUPPL2021-07-26
63704SUPPL2020-06-25
63694SUPPL2020-06-25
63693SUPPL2020-06-25
61735ORIG2020-01-29
59434ORIG2019-07-24
59395ORIG2019-07-22
59389ORIG2019-07-22
62971ORIG1900-01-01