Application 021197

Type
NDA
Sponsor
EMD SERONO INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CETROTIDECETRORELIXINJECTABLE;INJECTIONEQ 0.25MG BASE/MLYesYes
002CETROTIDECETRORELIXINJECTABLE;INJECTIONEQ 3MG BASE/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
44087-1225Cetrotidecetrorelix acetateEMD Serono, Inc.NDACurrent
44087-1225Cetrotidecetrorelix acetateEMD Serono, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80243SUPPL 2024-11-19
78642SUPPL 2024-06-05
78637SUPPL 2024-06-05
77116SUPPL 2023-12-22
77115SUPPL 2023-12-22
77087SUPPL 2023-12-19
77086SUPPL 2023-12-19
77047SUPPL 2023-12-19
77046SUPPL 2023-12-19
68282SUPPL2021-08-04
36324SUPPL2008-04-16
27042SUPPL2008-04-10
27041SUPPL2004-05-07
4613SUPPL2004-05-07
4612SUPPL2004-05-07
27040ORIG2000-08-11
21504ORIG2000-08-11
14622ORIG2000-08-11