Drugs@FDA: FDA Approved Drug Products

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

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 PHARMACIA AND UPJOHN
IBUTILIDE FUMARATE IBUTILIDE FUMARATE 0.1MG/ML INJECTABLE;INJECTION Prescription No AP 090643 MYLAN INSTITUTIONAL

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