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IBUTILIDE FUMARATE

ANDA

IBUTILIDE FUMARATE | A090643 | PHARMOBEDIENT CONSULTING LLC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: CORVERT(TE code: AP)

API Supply Chain2 active DMFs1 inactive

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

SAI LIFE SCIENCES LTDIBUTILIDE FUMARATE USP

DMF 214702008

EMCURE PHARMACEUTICALS LTDIBUTILIDE FUMARATE USP

DMF 257632012

SAI ADVANTIUM PHARMA LTDInactiveIBUTILIDE FUMARATE

DMF 202522007

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jan 15, 2010	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.1MG/ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Jan 11, 2010

No patent or exclusivity listings for this strength.