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CISPLATIN

ANDA

CISPLATIN | A075036 | HIKMA PHARMACEUTICALS USA INC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: CISPLATIN(TE code: AP)

API Supply Chain6 active DMFs6 inactive

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

HERAEUS PRECIOUS METALS GMBH AND CO KGCISPLATIN USP

DMF 66621986

VERANOVA LPCISPLATIN

DMF 96011992

LAURUS LABS LTDCISPLATIN USP DRUG SUBSTANCE

DMF 219172008

QILU PHARMACEUTICAL CO LTDCISPLATIN (NON STERILE API)

DMF 239852010

UMICORE ARGENTINA SACISPLATIN

DMF 280462014

HETERO LABS LTDCISPLATIN USP

DMF 288012014

ENGELHARD MINERALS AND CHEMICAL CORPInactiveCISPLATIN

DMF 40981981

PLANTEX LTD CHEMICAL AND PHARMACEUTICAL WORKSInactiveCISPLATIN

DMF 48241983

SOCIETE FRANCAISE D'ORGANOInactiveCISPLATIN

DMF 51891983

TAMILNADU DADHA PHARMACEUTICALInactiveCISPLATIN

DMF 79651989

INSTITUTE DRUG TECHNOLOGY AUSTRALIA LTDInactiveCISPLATIN DRUG SUBSTANCE

DMF 108981994

DEGUSSA AG WERK RADEBEULInactiveCISPLATIN

DMF 120121996

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jun 1, 2004	ORIG -1	View Letter (PDF)
Nov 7, 2000	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1MG/ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Nov 7, 2000

No patent or exclusivity listings for this strength.