FDA.reportPublic FDA data

Application 021057

Type
NDA
Sponsor
ORGANON USA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GANIRELIX ACETATEGANIRELIX ACETATEINJECTABLE;INJECTION250MCG/0.5MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0052-0301Ganirelix AcetateGanirelix AcetateOrganon USA Inc.NDACurrent
0052-0301Ganirelix AcetateGanirelix AcetateOrganon USA Inc.NDACurrent
0052-0301Ganirelix AcetateGanirelix AcetateOrganon USA Inc.NDACurrent
78206-138Ganirelix AcetateGanirelix AcetateOrganon LLCNDACurrent
78206-138Ganirelix AcetateGanirelix AcetateOrganon LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79728SUPPL 2024-09-24
79708SUPPL 2024-09-24
75085SUPPL 2023-08-16
75084SUPPL 2023-08-16
75083SUPPL 2023-08-16
75082SUPPL 2023-08-16
75076SUPPL 2023-08-15
75075SUPPL 2023-08-15
75074SUPPL 2023-08-15
75073SUPPL 2023-08-15
65862SUPPL2021-01-07
65085SUPPL2020-10-30
14259SUPPL2015-01-09
4180SUPPL2014-12-23
4179SUPPL2008-07-02
14258SUPPL2008-06-30
21399ORIG2004-05-27
14257ORIG1999-07-29
4178ORIG1999-07-29