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IDARUBICIN HYDROCHLORIDE

ANDA

IDARUBICIN HYDROCHLORIDE | A065440 | FRESENIUS KABI USA LLC

3 strengths0 unique patents0 unique exclusivities

API Supply Chain1 active DMF3 inactive

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

TAPI NL BVIDARUBICIN HYDROCHLORIDE

DMF 138841998

PHARMACIA AND UPJOHN SUB PFIZER INCInactiveIDARUBICIN HYDROCHLORIDE

DMF 160572002

SYNBIAS PHARMA AGInactiveIDARUBICIN HYDROCHLORIDE

DMF 175042004

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveIDARUBICIN HYDROCHLORIDE USP

DMF 196132006

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

Products (3)

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#001 — 5MG/5ML (1MG/ML)

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Aug 4, 2009

No patent or exclusivity listings for this strength.

#002 — 10MG/10ML (1MG/ML)

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Aug 4, 2009

#003 — 20MG/20ML (1MG/ML)

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Aug 4, 2009