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TOPOTECAN HYDROCHLORIDE

NDA

TOPOTECAN HYDROCHLORIDE | N022453 | MEITHEAL PHARMACEUTICALS INC

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 Chain3 active DMFs5 inactive

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

SCINOPHARM TAIWAN LTDTOPOTECAN HYDROCHLORIDE DRUG SUBSTANCE

DMF 208102007

EMCURE PHARMACEUTICALS LTDTOPOTECAN HYDROCHLORIDE

DMF 234432010

NOVARTIS PHARMACEUTICALS CORPTOPOTECAN HYDROCHLORIDE

DMF 244582011

DR REDDYS LABORATORIES LTDInactiveTOPOTECAN HYDROCHLORIDE

DMF 198342006

SAI PHYTOCEUTICALS PVT LTDInactiveTOPOTECAN HYDROCHLORIDE

DMF 207232007

CIPLA LTDInactiveTOPOTECAN HYDROCHLORIDE

DMF 216212008

FRESENIUS KABI ONCOLOGY LTDInactiveTOPOTECAN HYDROCHLORIDE

DMF 223032009

SYNBIAS PHARMA LTDInactiveTOPOTECAN HYDROCHLORIDE

DMF 236822010

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

Approval Letters

5 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 4MG BASE/4ML (EQ 1MG BASE/ML)

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Dec 20, 2012

No patent or exclusivity listings for this strength.