Viewing data from:

CARBOPLATIN

ANDA

CARBOPLATIN | A208487 | INGENUS PHARMACEUTICALS LLC

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.

Products (4)

Sort:

#001 — 50MG/5ML (10MG/ML)

0 patents0 exclusivities▴

INJECTABLE;INTRAVENOUS | Approved: Apr 26, 2017

No patent or exclusivity listings for this strength.

#002 — 150MG/15ML (10MG/ML)

0 patents0 exclusivities▾

INJECTABLE;INTRAVENOUS | Approved: Apr 26, 2017

#003 — 450MG/45ML (10MG/ML)

0 patents0 exclusivities▾

INJECTABLE;INTRAVENOUS | Approved: Apr 26, 2017

#004 — 600MG/60ML (10MG/ML)

0 patents0 exclusivities▾

INJECTABLE;INTRAVENOUS | Approved: Apr 26, 2017

Change History (8)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

INGENUS PHARMS LLC became the listed applicant for Carboplatin NDA 208487, replacing NOVAST LABS.

Old: NOVAST LABS

New: INGENUS PHARMS LLC

MODIFIEDApplicant Full Name7/1/2026

Carboplatin (carboplatin) NDA 208487 applicant changed from NOVAST LABORATORIES LTD to INGENUS PHARMACEUTICALS LLC.

Old: NOVAST LABORATORIES LTD

New: INGENUS PHARMACEUTICALS LLC

MODIFIEDApplicant7/1/2026

Applicant for CARBOPLATIN (carboplatin) NDA 208487 changed from NOVAST LABS to INGENUS PHARMS LLC.

Old: NOVAST LABS

New: INGENUS PHARMS LLC

MODIFIEDApplicant7/1/2026

INGENUS PHARMS LLC assumed applicant responsibility for Carboplatin (NDA 208487, supplement 004) from NOVAST LABS.

Old: NOVAST LABS

New: INGENUS PHARMS LLC

MODIFIEDApplicant7/1/2026

Carboplatin NDA 208487 applicant changed from Novast Labs to Ingenus Pharms LLC.

Old: NOVAST LABS

New: INGENUS PHARMS LLC

MODIFIEDApplicant Full Name7/1/2026

Applicant for Carboplatin (NDA 208487, supplement 003) changed from Novast Laboratories Ltd to Ingenus Pharmaceuticals LLC.

Old: NOVAST LABORATORIES LTD

New: INGENUS PHARMACEUTICALS LLC

MODIFIEDApplicant Full Name7/1/2026

INGENUS PHARMACEUTICALS LLC acquired the NDA for Carboplatin (carboplatin) from NOVAST LABORATORIES LTD, as reflected in the applicant change for application A208487.

Old: NOVAST LABORATORIES LTD

New: INGENUS PHARMACEUTICALS LLC

MODIFIEDApplicant Full Name7/1/2026

Carboplatin NDA 208487 applicant changed from Novast Laboratories Ltd to Ingenus Pharmaceuticals LLC.

Old: NOVAST LABORATORIES LTD

New: INGENUS PHARMACEUTICALS LLC