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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090874
Company: MYLAN INSTITUTIONAL

Products on ANDA 090874

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ISOSULFAN BLUE	ISOSULFAN BLUE	50MG/5ML (10MG/ML)	SOLUTION;SUBCUTANEOUS	Prescription	AP	No	Yes
ISOSULFAN BLUE	ISOSULFAN BLUE	10MG/ML (10MG/ML)	SOLUTION;SUBCUTANEOUS	Prescription	None	No	Yes
ISOSULFAN BLUE	ISOSULFAN BLUE	30MG/3ML (10MG/ML)	SOLUTION;SUBCUTANEOUS	Prescription	None	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090874

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/20/2010	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090874s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/28/2026	SUPPL-8	Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 090874

ISOSULFAN BLUE

SOLUTION;SUBCUTANEOUS; 50MG/5ML (10MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ISOSULFAN BLUE	ISOSULFAN BLUE	50MG/5ML (10MG/ML)	SOLUTION;SUBCUTANEOUS	Prescription	No	AP	210294	AM REGENT
ISOSULFAN BLUE	ISOSULFAN BLUE	50MG/5ML (10MG/ML)	SOLUTION;SUBCUTANEOUS	Prescription	No	AP	206831	EUGIA PHARMA
ISOSULFAN BLUE	ISOSULFAN BLUE	50MG/5ML (10MG/ML)	SOLUTION;SUBCUTANEOUS	Prescription	No	AP	213130	MEITHEAL
ISOSULFAN BLUE	ISOSULFAN BLUE	50MG/5ML (10MG/ML)	SOLUTION;SUBCUTANEOUS	Prescription	No	AP	216090	MSN
ISOSULFAN BLUE	ISOSULFAN BLUE	50MG/5ML (10MG/ML)	SOLUTION;SUBCUTANEOUS	Prescription	No	AP	090874	MYLAN INSTITUTIONAL
ISOSULFAN BLUE	ISOSULFAN BLUE	50MG/5ML (10MG/ML)	SOLUTION;SUBCUTANEOUS	Prescription	No	AP	210558	SOMERSET THERAPS LLC

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