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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 203385

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NDA 203385 describes DACTINOMYCIN, which is a drug marketed by Am Regent, Eugia Pharma, Hikma, Hisun Pharm Hangzhou, Meitheal, and Xgen Pharms, and is included in six NDAs. It is available from four suppliers. Additional details are available on the DACTINOMYCIN profile page.

The generic ingredient in DACTINOMYCIN is dactinomycin. There are three drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the dactinomycin profile page.

Summary for 203385

Tradename:	DACTINOMYCIN
Applicant:	Eugia Pharma
Ingredient:	dactinomycin
Patents:	0

Pharmacology for NDA: 203385

Mechanism of Action	Nucleic Acid Synthesis Inhibitors Protein Synthesis Inhibitors

Medical Subject Heading (MeSH) Categories for 203385

Anti-Bacterial Agents
Antibiotics, Antineoplastic
Nucleic Acid Synthesis Inhibitors
Protein Synthesis Inhibitors

Suppliers and Packaging for NDA: 203385

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DACTINOMYCIN	dactinomycin	INJECTABLE;INJECTION	203385	ANDA	Eugia US LLC	55150-431	55150-431-01	1 VIAL, SINGLE-DOSE in 1 CARTON (55150-431-01) / 1 mL in 1 VIAL, SINGLE-DOSE
DACTINOMYCIN	dactinomycin	INJECTABLE;INJECTION	203385	ANDA	Eugia US LLC	55150-928	55150-928-02	1 VIAL, SINGLE-DOSE in 1 CARTON (55150-928-02) / 1 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	0.5MG/VIAL
Approval Date:	Nov 9, 2017	TE:	AP	RLD:	No

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