FDA.reportPublic FDA data

Application 022219

Type
NDA
Sponsor
ENDO PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AVEEDTESTOSTERONE UNDECANOATEINJECTABLE;INTRAMUSCULAR750MG/3ML (250MG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
67979-511Aveedtestosterone undecanoateEndo Pharmaceuticals Inc.NDACurrent
67979-511Aveedtestosterone undecanoateEndo Pharmaceuticals Inc.NDACurrent
67979-511Aveedtestosterone undecanoateEndo Pharmaceuticals Inc.NDACurrent
67979-511Aveedtestosterone undecanoateEndo Pharmaceuticals Inc.NDACurrent
67979-511Aveedtestosterone undecanoateEndo Pharmaceuticals Inc.NDACurrent
67979-511Aveedtestosterone undecanoateEndo Pharmaceuticals Solutions Inc.NDACurrent
67979-511Aveedtestosterone undecanoateEndo Pharmaceuticals Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82871SUPPL 2025-07-15
82838SUPPL 2025-07-14
79844SUPPL 2024-10-09
71166SUPPL2022-05-31
68398SUPPL2021-08-18
68388SUPPL2021-08-17
67983SUPPL2021-06-30
63777SUPPL2020-07-02
63776SUPPL2020-07-02
63767SUPPL2020-07-01
62154SUPPL2020-03-17
62145SUPPL2020-03-16
60741SUPPL2019-10-31
60740SUPPL2019-10-31
60739SUPPL2019-10-31
56938SUPPL2018-12-21
55456SUPPL2018-09-12
52747ORIG2018-02-28
51908SUPPL2018-01-26
51904SUPPL2018-01-26
46131SUPPL2016-12-13
45746SUPPL2016-11-01
45676SUPPL2016-10-27
42454ORIG2016-03-28
38401SUPPL2015-05-13
7067SUPPL2015-05-13
38400SUPPL2015-03-05
29420SUPPL2015-03-04
38399SUPPL2014-06-23
7066SUPPL2014-06-23
24019ORIG2014-03-13
17098ORIG2014-03-06
7065ORIG2014-03-06