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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

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