FDA.reportPublic FDA data

Application 204150

Type
NDA
Sponsor
ALEMBIC PHARMS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DESVENLAFAXINEDESVENLAFAXINETABLET, EXTENDED RELEASE;ORAL50MGYesYes
002DESVENLAFAXINEDESVENLAFAXINETABLET, EXTENDED RELEASE;ORAL100MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
46708-152DesvenlafaxineDesvenlafaxineAlembic Pharmaceuticals LimitedNDACurrent
46708-153DesvenlafaxineDesvenlafaxineAlembic Pharmaceuticals LimitedNDACurrent
63304-191DesvenlafaxineDesvenlafaxineSun Pharmaceutical Industries, Inc.NDACurrent
63304-191DesvenlafaxineDesvenlafaxineSun Pharmaceutical Industries, Inc.NDACurrent
63304-191DesvenlafaxineDesvenlafaxineSun Pharmaceutical Industries, Inc.NDACurrent
63304-191DesvenlafaxineDesvenlafaxineSun Pharmaceutical Industries, Inc.NDACurrent
63304-192DesvenlafaxineDesvenlafaxineSun Pharmaceutical Industries, Inc.NDACurrent
63304-192DesvenlafaxineDesvenlafaxineSun Pharmaceutical Industries, Inc.NDACurrent
63304-192DesvenlafaxineDesvenlafaxineSun Pharmaceutical Industries, Inc.NDACurrent
63304-192DesvenlafaxineDesvenlafaxineSun Pharmaceutical Industries, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75260SUPPL 2023-08-22
75154SUPPL 2023-08-21
75153SUPPL 2023-08-21
68718SUPPL2021-09-22
68709SUPPL2021-09-21
68708SUPPL2021-09-21
60738SUPPL2019-10-30
60737SUPPL2019-10-30
60717SUPPL2019-10-30
50893SUPPL2017-12-27
50810SUPPL2017-12-21
50809SUPPL2017-12-21
46967SUPPL2017-01-24
46737SUPPL2017-01-10
46687SUPPL2017-01-06
45327SUPPL2016-09-15
40361SUPPL2015-05-21
32520SUPPL2015-05-19
32519SUPPL2014-07-09
10301SUPPL2014-07-09
40360SUPPL2014-07-08
40359SUPPL2014-07-08
24459ORIG2013-09-26
22945ORIG2013-09-26
40358ORIG2013-03-08
32518ORIG2013-03-05
32517ORIG2013-01-11
10300ORIG2013-01-07