Viewing data from:

IRINOTECAN HYDROCHLORIDE

ANDA

IRINOTECAN HYDROCHLORIDE | A203380 | QILU PHARMACEUTICAL HAINAN CO LTD

3 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: CAMPTOSAR(TE code: AP)

API Supply Chain14 active DMFs15 inactive

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

SCINOPHARM TAIWAN LTDIRINOTECAN HYDROCHLORIDE

DMF 173122004

PLIVA-LACHEMA ASIRINOTECAN HYDROCHLORIDE TRIHYDRATE

DMF 190502005

FERMION OYIRINOTECAN HYDROCHLORIDE

DMF 206492007

JIANGSU HENGRUI PHARMACEUTICALS CO LTDIRINOTECAN HYDROCHLORIDE USP (NON-STERILE BULK) DRUG SUBSTANCE

DMF 207392007

OLON SPAIRINOTECAN HYDROCHLORIDE TRIHYDRATE

DMF 215002008

LAURUS LABS LTDIRINOTECAN HYDROCHLORIDE TRIHYDRATE USP

DMF 222962008

EMCURE PHARMACEUTICALS LTDIRINOTECAN HYDROCHLORIDE USP

DMF 232202009

HUBEI HAOSUN PHARMACEUTICAL CO LTDIRINOTECAN HYDROCHLORIDE

DMF 235222010

SHILPA PHARMA LIFESCIENCES LTDIRINOTECAN HYDROCHLORIDE TRIHYDRATE USP

DMF 235622010

QILU PHARMACEUTICAL CO LTDIRINOTECAN HYDROCHLORIDE (NON STERILE, API)

DMF 241332010

ARCH PHARMALABS LTDIRINOTECAN HYDROCHLORIDE TRIHYDRATE USP

DMF 246432011

HETERO LABS LTDIRINOTECAN HYDROCHLORIDE TRIHYDRATE, USP (FORM B)

DMF 256862012

SUN PHARMACEUTICAL INDUSTRIES LTDIRINOTECAN HYDROCHLORIDE TRIHYDRATE

DMF 302612016

SUN PHARMACEUTICAL INDUSTRIES LTDIRINOTECAN HYDROCHLORIDE USP

DMF 326752018

CIPLA LTDInactiveIRINOTECAN HYDROCHLORIDE TRIHYDRATE USP

DMF 174562004

FRESENIUS KABI ONCOLOGY LTDInactiveIRINOTECAN HYDROCHLORIDE TRIHYDRATE

DMF 188182005

POLYMED THERAPEUTICS INCInactiveIRINOTECAN HYDROCHLORIDE TRIHYDRATE (NON-STERILE BULK) DRUG SUBSTANCE

DMF 189692005

SAI PHYTOCEUTICALS PVT LTDInactiveIRINOTECAN HYDROCHLORIDE TRIHYDRATE

DMF 196612006

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveIRINOTECAN HYDROCHLORIDE TRIHYDRATE

DMF 201952007

POLYMED THERAPEUTICS INCInactiveIRINOTECAN HYDROCHLORIDE TRIHYDRATE

DMF 202232007

DR REDDYS LABORATORIES LTDInactiveIRINOTECAN HYDROCHLORIDE TRIHYDRATE

DMF 203252007

LIANYUNGANG JARI PHARMACEUTICAL CO LTDInactiveIRINOTECAN HYDROCHLORIDE TRIHYDRATE

DMF 217462008

ALP PHARM BEIJING CO LTDInactiveIRINOTECAN HYDROCHLORIDE

DMF 239492010

CADILA HEALTHCARE LTDInactiveIRINOTECAN HYDROCHLORIDE USP

DMF 239822010

ZHEJIANG CHARIOTEER PHARMACEUTICAL CO LTDInactiveIRINOTECAN HYDROCHLORIDE

DMF 246532011

AVRA LABORATORIES PRIVATE LTDInactiveIRINOTECAN HYDROCHLORIDE USP

DMF 256932012

MAC CHEM PRODUCTS INDIA PVT LTDInactiveIRINOTECAN HYDROCHLORIDE TRIHYDRATE USP

DMF 265542012

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveIRINOTECAN HYDROCHLORIDE USP

DMF 277242013

AVRA LABORATORIES PRIVATE LTDInactiveIRINOTECAN HYDROCHLORIDE USP

DMF 305162016

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
May 6, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 40MG/2ML (20MG/ML)

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: May 3, 2016

No patent or exclusivity listings for this strength.

#002 — 100MG/5ML (20MG/ML)

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: May 3, 2016

#003 — 300MG/15ML (20MG/ML)

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: May 3, 2016