Dactinomycin
These highlights do not include all the information needed to use DACTINOMYCIN FOR INJECTION safely and effectively. See full prescribing information for DACTINOMYCIN FOR INJECTION.DACTINOMYCIN for injection, for intravenous use Initial U.S. Approval: 1964
Approved
Approval ID
2aaca42a-3b79-4151-a727-83253556a540
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 13, 2020
Manufacturers
FDA
Meitheal Pharmaceuticals Inc.
DUNS: 080548348
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 Code71288-129
Application NumberANDA213463
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dactinomycin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 31, 2020
FDA Product Classification
INGREDIENTS (3)
waterInactive
Code: 059QF0KO0R
Classification: IACT
dactinomycinActive
Quantity: 0.5 mg in 1 mL
Code: 1CC1JFE158
Classification: ACTIB
mannitolInactive
Code: 3OWL53L36A
Classification: IACT