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CARBOPLATIN

ANDA

CARBOPLATIN | A077139 | TEVA PHARMACEUTICALS USA

4 strengths0 unique patents0 unique exclusivities

API Supply Chain11 active DMFs7 inactive

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

VERANOVA LPCARBOPLATIN

DMF 71451987

HERAEUS PRECIOUS METALS GMBH AND CO KGCARBOPLATIN USP

DMF 151472000

STREM CHEMICALS INCCARBOPLATIN (USP)

DMF 159382002

SUN PHARMACEUTICAL INDUSTRIES LTDCARBOPLATIN USP

DMF 166642003

TAPI NL BVCARBOPLATIN

DMF 176592004

LAURUS LABS LTDCARBOPLATIN USP DRUG SUBSTANCE

DMF 219182008

QILU PHARMACEUTICAL CO LTDCARBOPLATIN USP

DMF 242012010

UMICORE ARGENTINA SACARBOPLATIN

DMF 280472014

KUNMING GUIYAN PHARMACEUTICAL CO LTDCARBOPLATIN DRUG SUBSTANCE

DMF 291002015

HETERO LABS LTDCARBOPLATIN USP

DMF 291672015

KUNMING GUIYAN PHARMACEUTICAL CO LTDCARBOPLATIN

DMF 417312025

LACHEMA BRNOInactiveCARBOPLATIN

DMF 95411992

PLIVA-LACHEMA ASInactiveCARBOPLATIN

DMF 162802002

INSTITUTE DRUG TECHNOLOGY AUSTRALIA LTDInactiveCARBOPLATIN

DMF 167092003

CIPLA LTDInactiveCARBOPLATIN USP

DMF 169162003

QILU PHARMACEUTICAL CO LTDInactiveCARBOPLATIN (NON-STERILE API)

DMF 236062010

FRESENIUS KABI ONCOLOGY LTDInactiveCARBOPLATIN

DMF 239952010

MAC CHEM PRODUCTS INDIA PVT LTDInactiveCARBOPLATIN USP

DMF 260292012

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Nov 4, 2014	SUPPL -16	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 50MG/5ML (10MG/ML)

0 patents0 exclusivities▴

INJECTABLE;INTRAVENOUS | Approved: Sep 21, 2005

No patent or exclusivity listings for this strength.

#002 — 150MG/15ML (10MG/ML)

0 patents0 exclusivities▾

INJECTABLE;INTRAVENOUS | Approved: Sep 21, 2005

#003 — 450MG/45ML (10MG/ML)

0 patents0 exclusivities▾

INJECTABLE;INTRAVENOUS | Approved: Sep 21, 2005

#004 — 600MG/60ML (10MG/ML)

0 patents0 exclusivities▾

INJECTABLE;INTRAVENOUS | Approved: Sep 21, 2005