List of Drug Master Files (DMF) of Urea, N'-((4-amino-2-methyl-5-pyrimidinyl)methyl)-N-(2-chloroethyl)-N-nitroso-, monohydrochloride Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

Data Compilation
#PharmaFlow

Stock Recap
#PipelineProspector

ACCESS ALL DATA, CHEMISTRY

2 API Suppliers, 2 USDMF

Xls download

Data in the table can be downloaded after upgrading. In the meantime, you can access the data through the menu.

Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
26/09/2024	Daiichi Sankyo	Japan	SANKYO CO LTD	5461	BULK FORM OF NIMUSTINE HCL (NIDRAN)	1984-07-20	Inactive	II	N/A
26/09/2024	Daiichi Sankyo	Japan	SANKYO CO LTD	5468	NIMUSTINE HCL (NIDRAN) IN VIALS	1984-07-20	Inactive	II	N/A

Urea, N'-((4-amino-2-methyl-5-pyrimidinyl)methyl)-N-(2-chloroethyl)-N-nitroso-, Monohydrochloride