FDA.reportPublic FDA data

Application 021529

Type
NDA
Sponsor
ORGANON USA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IMPLANONETONOGESTRELIMPLANT;IMPLANTATION68MG/IMPLANTNoNo
002NEXPLANONETONOGESTRELIMPLANT;IMPLANTATION68MG/IMPLANTYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0052-0272IMPLANONetonogestrelOrganon USA Inc.NDACurrent
0052-4330NexplanonetonogestrelOrganon USA Inc.NDACurrent
0052-4330NexplanonetonogestrelOrganon USA Inc.NDACurrent
0052-4330NexplanonetonogestrelOrganon USA Inc.NDACurrent
0052-4330NexplanonetonogestrelOrganon USA Inc.NDACurrent
0052-4330NexplanonetonogestrelOrganon USA Inc.NDACurrent
0052-4330NexplanonetonogestrelOrganon USA Inc.NDACurrent
0052-4330NexplanonetonogestrelOrganon USA Inc.NDACurrent
78206-145NexplanonetonogestrelOrganon LLCNDACurrent
78206-145NexplanonetonogestrelOrganon LLCNDACurrent
78206-145NexplanonetonogestrelOrganon LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84816SUPPL 2026-01-22
84805SUPPL 2026-01-22
75639SUPPL 2023-10-30
75637SUPPL 2023-10-30
75645SUPPL 2023-10-03
75644SUPPL 2023-10-03
75643SUPPL 2023-10-03
75638SUPPL 2023-10-02
72099SUPPL2022-09-16
72098SUPPL2022-09-16
72097SUPPL2022-09-16
72096SUPPL2022-09-16
72095SUPPL2022-09-16
71935SUPPL2022-08-26
64690SUPPL2020-09-25
64679SUPPL2020-09-25
64678SUPPL2020-09-25
58406SUPPL2019-04-25
58372SUPPL2019-04-24
48501SUPPL2017-05-23
48491SUPPL2017-05-23
28034SUPPL2016-03-16
37165SUPPL2016-03-15
5654SUPPL2015-08-21
15696SUPPL2015-08-20
37163SUPPL2014-07-09
37164SUPPL2013-10-01
28033SUPPL2013-10-01
37161SUPPL2012-02-06
5652SUPPL2012-02-03
5653SUPPL2011-05-19
37162SUPPL2011-05-16
42202ORIG2009-11-19
5651SUPPL2009-02-23
37160SUPPL2009-02-20
5650SUPPL2007-01-25
37159ORIG2006-07-21
28032ORIG2006-07-21