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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090643
Company: MYLAN INSTITUTIONAL

Products on ANDA 090643

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IBUTILIDE FUMARATE	IBUTILIDE FUMARATE	0.1MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090643

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/11/2010	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090643s000ltr.pdf

Therapeutic Equivalents for ANDA 090643

IBUTILIDE FUMARATE

INJECTABLE;INJECTION; 0.1MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CORVERT	IBUTILIDE FUMARATE	0.1MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	020491	PFIZER
IBUTILIDE FUMARATE	IBUTILIDE FUMARATE	0.1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	204146	AVET LIFESCIENCES
IBUTILIDE FUMARATE	IBUTILIDE FUMARATE	0.1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	090643	MYLAN INSTITUTIONAL

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