FDA.reportPublic FDA data

Application 204683

Type
NDA
Sponsor
OSMOTICA PHARM CORP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KHEDEZLADESVENLAFAXINETABLET, EXTENDED RELEASE;ORAL50MGNoNo
002KHEDEZLADESVENLAFAXINETABLET, EXTENDED RELEASE;ORAL100MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
44183-880DesvenlafaxinedesvenlafaxineMacoven PharmaceuticalsNDA AUTHORIZED GENERICCurrent
44183-880DesvenlafaxinedesvenlafaxineMacoven PharmaceuticalsNDA AUTHORIZED GENERICCurrent
44183-890DesvenlafaxinedesvenlafaxineMacoven PharmaceuticalsNDA AUTHORIZED GENERICCurrent
44183-890DesvenlafaxinedesvenlafaxineMacoven PharmaceuticalsNDA AUTHORIZED GENERICCurrent
65224-880KHEDEZLAdesvenlafaxinePernix TherapeuticsNDACurrent
65224-880KHEDEZLAdesvenlafaxinePernix TherapeuticsNDACurrent
65224-890KHEDEZLAdesvenlafaxinePernix TherapeuticsNDACurrent
65224-890KHEDEZLAdesvenlafaxinePernix TherapeuticsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68825SUPPL2021-09-30
68824SUPPL2021-09-30
68736SUPPL2021-09-23
57539SUPPL2019-02-13
57386SUPPL2019-01-30
57385SUPPL2019-01-30
50897SUPPL2017-12-27
50805SUPPL2017-12-21
50804SUPPL2017-12-21
46773SUPPL2017-01-10
46715SUPPL2017-01-06
45276SUPPL2016-09-07
45245SUPPL2016-09-06
40413SUPPL2014-07-17
32583SUPPL2014-07-17
44906ORIG2014-03-06
22962ORIG2014-03-06
32582SUPPL2013-10-01
40412SUPPL2013-09-30
32581ORIG2013-07-12
19587ORIG2013-07-11