Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210294
Company: AM REGENT

Products on ANDA 210294

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ISOSULFAN BLUE	ISOSULFAN BLUE	1%	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210294

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/17/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 210294

ISOSULFAN BLUE

INJECTABLE;INJECTION; 1%
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ISOSULFAN BLUE	ISOSULFAN BLUE	1%	INJECTABLE;INJECTION	Prescription	No	AP	210294	AM REGENT
ISOSULFAN BLUE	ISOSULFAN BLUE	1%	INJECTABLE;INJECTION	Prescription	No	AP	213130	MEITHEAL
ISOSULFAN BLUE	ISOSULFAN BLUE	1%	INJECTABLE;INJECTION	Prescription	No	AP	216090	MSN
ISOSULFAN BLUE	ISOSULFAN BLUE	1%	INJECTABLE;INJECTION	Prescription	No	AP	090874	MYLAN INSTITUTIONAL