An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 203999
Company: XGEN PHARMS

Products on ANDA 203999

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DACTINOMYCIN	DACTINOMYCIN	0.5MG/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203999

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/20/2019	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 203999

DACTINOMYCIN

INJECTABLE;INJECTION; 0.5MG/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DACTINOMYCIN	DACTINOMYCIN	0.5MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	203385	EUGIA PHARMA
DACTINOMYCIN	DACTINOMYCIN	0.5MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	207232	HISUN PHARM HANGZHOU
DACTINOMYCIN	DACTINOMYCIN	0.5MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	213463	MEITHEAL
DACTINOMYCIN	DACTINOMYCIN	0.5MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	203999	XGEN PHARMS

Top