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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208231
Company: FRESENIUS KABI USA

Products on ANDA 208231

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ARSENIC TRIOXIDE	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208231

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/31/2018	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208231Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/11/2023	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
10/11/2023	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 208231

ARSENIC TRIOXIDE

INJECTABLE;INJECTION; 1MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ARSENIC TRIOXIDE	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	210739	AMNEAL
ARSENIC TRIOXIDE	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	210802	AMRING PHARMS
ARSENIC TRIOXIDE	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	208231	FRESENIUS KABI USA
ARSENIC TRIOXIDE	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	215059	GLAND PHARMA LTD
ARSENIC TRIOXIDE	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	209315	INGENUS PHARMS LLC
ARSENIC TRIOXIDE	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	209780	NEXUS
ARSENIC TRIOXIDE	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	217413	ORBICULAR
ARSENIC TRIOXIDE	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	209873	PENN LIFE
ARSENIC TRIOXIDE	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	206228	ZYDUS PHARMS

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