Viewing data from:

TEMODAR

NDA

TEMOZOLOMIDE | N022277 | MERCK SHARP AND DOHME CORP

1 strength0 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 Chain13 active DMFs1 inactive

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

WAVELENGTH ENTERPRISES LTDTEMOZOLOMIDE

DMF 193472006

JIANGSU TASLY DIYI PHARMACEUTICAL CO LTDTEMOZOLOMIDE (BULK, NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT)

DMF 216692008

RELIANCE LIFE SCIENCES PVT LTDTEMOZOLOMIDE USP

DMF 227752009

FORMOSA LABORATORIES INCTEMOZOLOMIDE

DMF 231582009

SHILPA PHARMA LIFESCIENCES LTDTEMOZOLOMIDE USP

DMF 234792010

CHEMWERTH INCTEMOZOLOMIDE (NON-STERILE BULK DRUG SUBSTANCE)

DMF 235472010

SUN PHARMACEUTICAL INDUSTRIES LTDTEMOZOLOMIDE USP

DMF 235532010

GLOPEC INTERNATIONAL INCTEMOZOLOMIDE

DMF 241732010

SYNTHIMED LABS PRIVATE LTDTEMOZOLOMIDE USP

DMF 242982010

BEIJING LUNARSUN PHARMACEUTICAL CO LTDTEMOZOLOMIDE

DMF 243522010

EXCELLA GMBH AND CO KGTEMOZOLOMIDE

DMF 260322012

HUBEI HAOSUN PHARMACEUTICAL CO LTDTEMOZOLOMIDE

DMF 277152013

AMPAC FINE CHEMICALS LLCTEMOZOLOMIDE

DMF 285802014

CIPLA LTDInactiveTEMOZOLOMIDE USP

DMF 290282015

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

Approval Letters

14 letters from Drugs@FDA

Date	Submission	Document
Sep 15, 2023	SUPPL -19	View Letter (PDF)
Sep 15, 2023	SUPPL -18	View Letter (PDF)
Sep 15, 2023	SUPPL -17	View Letter (PDF)
Nov 25, 2020	SUPPL -14	View Letter (PDF)
Nov 26, 2019	SUPPL -13	View Letter (PDF)
Oct 12, 2017	SUPPL -12	View Letter (PDF)
Mar 2, 2017	SUPPL -10	View Letter (PDF)
Feb 16, 2016	SUPPL -11	View Letter (PDF)
Sep 22, 2015	SUPPL -9	View Letter (PDF)
Apr 3, 2015	SUPPL -8	View Letter (PDF)
May 6, 2014	SUPPL -7	View Letter (PDF)
Jun 9, 2011	SUPPL -5	View Letter (PDF)
Apr 29, 2010	SUPPL -1	View Letter (PDF)
Mar 5, 2009	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 100MG/VIAL

RLD

0 patents0 exclusivities▴

POWDER;INTRAVENOUS | Approved: Feb 27, 2009

No patent or exclusivity listings for this strength.