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FLOXURIDINE

ANDA

FLOXURIDINE | A075387 | HIKMA PHARMACEUTICALS USA INC

1 strength0 unique patents0 unique exclusivities

API Supply Chain1 active DMF4 inactive

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

RELIABLE BIOPHARMACEUTICAL LLCFLOXURIDINE

DMF 153522001

PCR INCInactiveFLOXURIDINE

DMF 77981989

NYCOMED AUSTRIA GMBHInactiveFLOXURIDINE

DMF 140061999

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveFLOXURIDINE USP

DMF 147902000

DSM FINE CHEMICALS INCInactiveFLOXURIDINE

DMF 149652000

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 6, 2000	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 500MG/VIAL

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Apr 16, 2000

No patent or exclusivity listings for this strength.