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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 202562

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NDA 202562 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 202562

Tradename:	DACTINOMYCIN
Applicant:	Am Regent
Ingredient:	dactinomycin
Patents:	0

Medical Subject Heading (MeSH) Categories for 202562

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	0.5MG/VIAL
Approval Date:	Aug 23, 2013	TE:		RLD:	No

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