Cosmegen
These highlights do not include all the information needed to use COSMEGEN safely and effectively. See full prescribing information for COSMEGEN. Initial U.S. Approval: 1964
Approved
Approval ID
9914e793-a49c-eb00-1ab7-f606c786fe25
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 18, 2024
Manufacturers
FDA
Recordati Rare Diseases, Inc.
DUNS: 181699406
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
dactinomycin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55292-811
Application NumberNDA050682
Product Classification
M
Marketing Category
C73594
G
Generic Name
dactinomycin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 18, 2024
FDA Product Classification
INGREDIENTS (2)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
DACTINOMYCINActive
Quantity: 0.5 mg in 1 mL
Code: 1CC1JFE158
Classification: ACTIB