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MITOXANTRONE HYDROCHLORIDE

ANDA

MITOXANTRONE HYDROCHLORIDE | A076611 | HIKMA PHARMACEUTICALS USA INC

3 strengths0 unique patents0 unique exclusivities

API Supply Chain3 active DMFs4 inactive

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

CHONGQING CARELIFE PHARMACEUTICAL CO LTDMITOXANTRONE HYDROCHLORIDE USP

DMF 122621996

IDT AUSTRALIA LTDMITOXANTRONE HYDROCHLORIDE USP

DMF 123281997

CHONGQING CARELIFE PHARMACEUTICAL CO LTDMITOXANTRONE HYDROCHLORIDE

DMF 432532025

CIPLA LTDInactiveMITOXANTRONE HYDROCHLORIDE

DMF 108581994

SYNTHESIA ASInactiveMITOXANTRONE HYDROCHLORIDE USP

DMF 120461996

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveMITOXANTRONE HYDROCHLORIDE USP

DMF 158792002

CIPLA LTDInactiveMITOXANTRONE HYDROCHLORIDE USP

DMF 193092007

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Apr 13, 2006	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

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#001 — EQ 20MG BASE/10ML (EQ 2MG BASE/ML)

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Apr 11, 2006

No patent or exclusivity listings for this strength.

#002 — EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Apr 11, 2006

#003 — EQ 30MG BASE/15ML (EQ 2MG BASE/ML)

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Apr 11, 2006