Viewing data from:

VEPESID

NDA

ETOPOSIDE | N019557 | ONESOURCE SPECIALTY PTE LTD

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain6 active DMFs7 inactive

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

JIANGSU HENGRUI PHARMACEUTICALS CO LTDETOPOSIDE USP

DMF 86471990

NIPPON KAYAKU CO LTDETOPOSIDE

DMF 89461991

TAPI NL BVETOPOSIDE

DMF 99661992

CIPLA LTDETOPOSIDE USP

DMF 106421993

SICHUAN HUIYU PHARMACEUTICAL CO LTDETOPOSIDE

DMF 409282025

SHANDONG ANHONG PHARMACEUTICAL CO LTDETOPOSIDE

DMF 413082025

SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL DEVELOPMENTInactiveETOPOSIDE (VP 16-213) (ETHYLIDENE)

DMF 43851981

OMNICHEM NVInactiveETOPOSIDE

DMF 86961990

PLANTEX LTD CHEMICAL AND PHARMACEUTICAL WORKSInactiveETOPOSIDE

DMF 95461992

PHARMACEUTICAL FACTORY SHANGHAI INSTITUTE PHARMACEUTICAL INDUSTRYInactiveETOPOSIDE

DMF 101911993

RP SCHERER CANADA INCInactiveETOPOSIDE 50MG SOFT-GELATIN CAPSULE

DMF 139861999

QILU PHARMACEUTICAL CO LTDInactiveETOPOSIDE (NON-STERILE API)

DMF 243322010

SEACROSS PHARMA USA INCInactiveETOPOSIDE

DMF 387792023

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 5, 2002	SUPPL -28	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 50MG

RLDAB

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Dec 30, 1986

No patent or exclusivity listings for this strength.

#002 — 100MG

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Dec 30, 1986