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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

5e1a64c2-283a-51a7-e053-2991aa0af15f

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 18, 2024

Manufacturers
FDA

Prasco Laboratories

DUNS: 065969375

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 Code66993-489
Application NumberNDA050682
Product Classification
M
Marketing Category
C73605
G
Generic Name
Dactinomycin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 18, 2024
FDA Product Classification

INGREDIENTS (2)

DACTINOMYCINActive
Quantity: 0.5 mg in 1 mL
Code: 1CC1JFE158
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT

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Dactinomycin - FDA Drug Approval Details