dactinomycin

Basic Information

Product Name

dactinomycin

FDA Product Code

39822-2100

Regulatory Information

NDC Product Code

39822-2100

Application Number

ANDA203999

Marketing Category

C73584

Effective Date

February 23, 2021

Territorial Authority

USA

FDA Title

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 Rx Only

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

DACTINOMYCIN

Quantity: 0.5 mg in 1 mL

Code: 1CC1JFE158

Class Code: ACTIB

MANNITOL

Code: 3OWL53L36A

Class Code: IACT

Active Moieties

Code: 1CC1JFE158

dactinomycin

Basic Information

Regulatory Information

Company Information

Active Ingredients

MANNITOL

Active Moieties

DACTINOMYCIN