Application 022239

Type
NDA
Sponsor
ENDO VENTURES LTD

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001SUMAVEL DOSEPROSUMATRIPTAN SUCCINATEINJECTABLE;SUBCUTANEOUSEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)YesNo
002SUMAVEL DOSEPROSUMATRIPTAN SUCCINATEINJECTABLE;SUBCUTANEOUSEQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)YesNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
43376-104Sumavel DoseProsumatriptanZogenix, Inc.NDACurrent
43376-106Sumavel DoseProsumatriptanZogenix, Inc.NDACurrent
63481-367Sumavel DoseProsumatriptanEndo Pharmaceuticals, Inc.NDACurrent

Documents

DocumentSubmission typeDate
63807SUPPL2020-07-06
63798SUPPL2020-07-06
61500SUPPL2020-01-02
61461SUPPL2019-12-27
17111SUPPL2016-06-06
38412SUPPL2013-12-12
7078SUPPL2013-11-27
29433SUPPL2011-07-05
38411SUPPL2011-06-27
44711ORIG2010-06-22
21966ORIG2010-06-22
17110ORIG2009-07-23
7077ORIG2009-07-20