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EPIRUBICIN HYDROCHLORIDE

ANDA

EPIRUBICIN HYDROCHLORIDE | A065408 | FRESENIUS KABI USA LLC

4 strengths0 unique patents0 unique exclusivities

API Supply Chain7 active DMFs3 inactive

5 active API suppliers hold Drug Master Files for this ingredient.

SYNBIAS PHARMA AGEPIRUBICIN HYDROCHLORIDE

DMF 162582002

TAPI NL BVEPIRUBICIN HYDROCHLORIDE LYOPHILIZED

DMF 183072005

SHANDONG NEW TIME PHARMACEUTICAL CO LTDEPIRUBICIN HYDROCHLORIDE

DMF 198182006

TAPI NL BVEPIRUBICIN HYDROCHLORIDE PRECIPITATED

DMF 213032008

MICROBIOPHARM JAPAN CO LTDEPIRUBICIN HYDROCHLORIDE

DMF 220182008

DZD (HEZE) PHARMACEUTICAL CO LTDEPIRUBICIN HYDROCHLORIDE

DMF 313732017

SHANDONG NEW TIME PHARMACEUTICAL CO LTDEPIRUBICIN HYDROCHLORIDE USP

DMF 380602023

FARMITALIA CARLO ERBA SPAInactiveEPIRUBICIN HYDROCHLORIDE

DMF 53591984

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveEPIRUBICIN HYDROCHLORIDE

DMF 163242002

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveEPIRUBICIN HYDROCHLORIDE (LYOPHILIZED) NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT

DMF 184982005

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

Products (4)

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#001 — 10MG/5ML (2MG/ML)

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Oct 15, 2007

No patent or exclusivity listings for this strength.

#002 — 50MG/25ML (2MG/ML)

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Oct 15, 2007

#003 — 150MG/75ML (2MG/ML)

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Oct 15, 2007

#004 — 200MG/100ML (2MG/ML)

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Oct 15, 2007