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OXALIPLATIN

ANDA

OXALIPLATIN | A207562 | INGENUS PHARMACEUTICALS LLC

2 strengths0 unique patents0 unique exclusivities

API Supply Chain17 active DMFs8 inactive

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

TANAKA KIKINZOKU KOGYOOXALIPLATIN

DMF 100401993

VERANOVA LPOXALIPLATIN

DMF 169522003

TAPI NL BVOXALIPLATIN

DMF 195592006

PLIVA-LACHEMA ASOXALIPLATIN

DMF 195942006

HERAEUS PRECIOUS METALS GMBH AND CO KGOXALIPLATIN

DMF 196332006

SUN PHARMACEUTICAL INDUSTRIES LTDOXALIPLATIN USP

DMF 196482006

HERAEUS PRECIOUS METALS GMBH AND CO KGOXALIPLATIN PROCESS HER-2 USP

DMF 200542006

JIANGSU HENGRUI PHARMACEUTICALS CO LTDOXALIPLATIN USP

DMF 206652007

LAURUS LABS LTDOXALIPLATIN USP

DMF 223872008

QILU PHARMACEUTICAL CO LTDOXALIPLATIN USP (NON-STERILE API)

DMF 235302010

SHILPA PHARMA LIFESCIENCES LTDOXALIPLATIN USP

DMF 235632010

EMCURE PHARMACEUTICALS LTDOXALIPLATIN USP

DMF 245592011

VUAB PHARMA ASOXALIPLATIN USP

DMF 262672012

UMICORE ARGENTINA SAOXALIPLATIN

DMF 280432014

HETERO LABS LTDOXALIPLATIN USP

DMF 289132014

KUNMING GUIYAN PHARMACEUTICAL CO LTDOXALIPLATIN DRUG SUBSTANCE

DMF 294302015

KUNMING GUIYAN PHARMACEUTICAL CO LTDOXALIPLATIN

DMF 410282025

FRESENIUS KABI ONCOLOGY LTDInactiveOXALIPLATIN

DMF 196102006

CIPLA LTDInactiveOXALIPLATIN PH. EUR.

DMF 201682008

CADILA HEALTHCARE LTDInactiveOXALIPLATIN PH EUR

DMF 231012009

HOSPIRA INCInactiveOXALIPLATIN DRUG SUBSTANCE

DMF 243672010

JARI PHARMACEUTICAL CO LTDInactiveOXALIPLATIN

DMF 256812012

HUBEI HAOSUN PHARMACEUTICAL CO LTDInactiveOXALIPLATIN

DMF 261072012

MAC CHEM PRODUCTS INDIA PVT LTDInactiveOXALIPLATIN USP

DMF 270282013

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveOXALIPLATIN USP

DMF 277622013

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

Products (2)

Sort:

#001 — 50MG/10ML (5MG/ML)

0 patents0 exclusivities▴

INJECTABLE;INTRAVENOUS | Approved: Oct 16, 2018

No patent or exclusivity listings for this strength.

#002 — 100MG/20ML (5MG/ML)

0 patents0 exclusivities▾

INJECTABLE;INTRAVENOUS | Approved: Oct 16, 2018

Change History (4)

Recent changes detected for this application.

MODIFIEDApplicant Full Name7/1/2026

Applicant for oxaliplatin NDA 207562 changed from Novast Laboratories Ltd to Ingenus Pharmaceuticals LLC.

Old: NOVAST LABORATORIES LTD

New: INGENUS PHARMACEUTICALS LLC

MODIFIEDApplicant7/1/2026

Applicant for oxaliplatin NDA 207562 changed from Novast Labs to Ingenus Pharms LLC.

Old: NOVAST LABS

New: INGENUS PHARMS LLC