Application 006695

Type
NDA
Sponsor
RECORDATI RARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MUSTARGENMECHLORETHAMINE HYDROCHLORIDEINJECTABLE;INJECTION10MG/VIALYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55292-911Mustargenmechlorethamine hydrochlorideRECORDATI RARE DISEASES, NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
32944SUPPL2004-04-05
81SUPPL2004-03-02
30SUPPL2003-03-26